If you’re like me, you’ve probably seen numerous Internet ads for a new medication called Nuedexta from Avanir Pharmaceuticals. Nuedexta was approved in October 2010 for the treatment of “pseudobulbar affect,” or PBA. My first reaction was one of surprise, as PBA is relatively uncommon, or so I was taught: why would a drug company be aggressively advertising a drug with such a niche market? However, as I thought about the symptoms that define PBA—and then, last week, I received a Nuedexta promotional packet in the mail—I figured I should take a look “under the hood.”
First of all, I reviewed the presentation and biology of PBA. I remember being taught in residency that it is a fairly uncommon manifestation of neurological illness, although it has a very distinctive presentation, namely, emotional expressions that are disconnected from any subjective emotional changes. Indeed, an alternate name for it is “pathological laughing and crying.” Certainly, the discrepancy between a patient’s emotional display—which may be extreme, and cause great distress to caregivers—and the lack of any subjective change in mood, is highly suggestive of a focal brain abnormality.
PBA is typically caused by a specific brain lesion between the cortex (the source of voluntary thought/action) and the brainstem (the source of involuntary emotional expression like laughing and crying). Normally, we’re stimulated to laugh or cry by something funny or sad; these emotions are first processed in the cortex, which then sends a message to the brainstem to express that emotion. If you have a lesion between your cortex and brainstem (e.g., from a stroke, multiple sclerosis, or a degenerative process) then the emotional expression can be entirely separated from the conscious awareness of it.
Over the last decade some research groups have begun to look at dextromethorphan as a potential treatment for PBA. Dextromethorphan, also known as DXM, is a cough suppressant, the active ingredient in Robitussin, not to mention a drug often used recreationally for its dissociative and hallucinogenic properties. Dextromethorphan is an NMDA antagonist (i.e., it prevents glutamate from activating target cells via NMDA receptors) as well as an agonist of a type of receptor called “sigma-1,” whose role is much less understood.
When dextromethorphan is combined with quinidine, another widely available drug (used to treat heart arrhythmias), the quinidine inhibits dextromethorphan’s metabolism, allowing it to penetrate the brain at doses low enough to avoid any peripheral toxicity. Once inside the brain, it “may act on regions implicated in emotional expression” (by an unknown mechanism) and, indeed, it improves PBA symptoms with the only significant side effects being dizziness and diarrhea. The new drug Nuedexta is a combination of 20 mg dextromethorphan and 10 mg quinidine, and the estimated cost will be from $3000-$5000 per year.
(BTW, note the theme here, which is similar to what I wrote about with Contrave: Nuedexta is actually a combination of two existing, generic—i.e., cheap—drugs, with a significant markup, to cover the costs of clinical testing, marketing, and, of course, shareholder profits.)
Physicians—and patients—may wonder why we need a new drug to treat PBA. Certainly, this is a good question (although I think PBA is simply Avanir’s “foot in the door,” as I’ll discuss below). A 2007 review in the Annals of Neurology shows that a number of medications, including SSRIs like citalopram, and tricyclic antidepressants (TCAs), are effective in managing the symptoms of PBA (see also here). And, as I mentioned earlier, the proper diagnosis of PBA requires the presence of an underlying neurological disorder, and treatment of the disorder, too, may ameliorate the PBA symptoms.
Interestingly, while I searched for literature references discussing PBA, I found that most—if not all—of the literature from the last 5-6 years has been funded or underwritten by Avanir Pharmaceuticals—and all of which discussed the benefits of dextromethorphan/quinidine. This included an “educational review” published by the National Stroke Association in 2005. In fact, the editors of the Annals of Neurology issue I cited above tried to get someone to write a review on PBA but couldn’t find any authors “untouched by Avanir.” It certainly seems that Avanir’s PR effort has paid off.
The coup de grâce, in my opinion, is an “expert review” on PBA published in the journal CNS Spectrums in October 2005. It’s a roundtable discussion on how to distinguish PBA from other psychiatric and neurologic disorders—and, of course, the benefits of dextromethorphan/quinidine. It seems like a fair review, although the authors make comments that broaden the definition of PBA to include other disturbances of affect, which are extremely common among psychiatric patients. “It may be useful to regard affective lability,” they write, “as a disorder of affect that exists at a point on a continuum between normal affective variability and the more severe end of the continuum characterized by [PBA].” Furthermore, they encourage clinicians to “include a specific assessment for PBA” in all patients with any neurological condition, to prevent their being “misdiagnosed” with a psychiatric disorder—the implication being that what we might call “poststroke depression” might actually be PBA. And they even open the door to the possibility that “PBA-like” symptoms might not have a recognizable neurological basis: “In some cases PBA may be the only clinically identifiable manifestation of the neurological condition. In light of the overlap between the neurology of affect regulation and the neurology of psychiatric conditions, … PBA may sometimes occur in the latter context as well.” [Emphasis mine.]
You can see where this is all headed—and probably why I received a promotional packet for Nuedexta, even though I’m not a neurologist. Here we have a new medication, which has been approved for a neurological syndrome whose major manifestation is “affective instability.” Even though the proper diagnosis of PBA requires far more than that, clinicians will undoubtedly use it off-label for the affective lability seen in many other conditions (such as bipolar disorder, schizophrenia, autism, dementia, maybe even childhood irritability, etc). And my bet is that Avanir will try to get Nuedexta approved for all of these conditions.
(BTW, Nuedexta has never been compared head-to-head with SSRIs or TCAs, and the trials which led to Nuedexta’s approval showed only slight improvement vs. placebo in patients with PBA due to multiple sclerosis and ALS.)
Indeed, Avanir’s investor materials (see pdf here) already state that the company will seek approval for multiple sclerosis-related pain, and for behavioral symptoms in dementia. And when one considers how atypical antipsychotics have been affected by “indication creep,” it is probably only a matter of time before Nuedexta will be tested for other disorders characterized by affective changes, including the big kahunas: depression and bipolar disorder. To that end, during a November 2009 conference call to shareholders, Keith Katkin, Avanir’s CEO, described Nuedexta as a “pipeline in a pill.”
I should note here that I have not tried Nuedexta so I can’t say whether it is effective. I also have no financial interest in Avanir Pharmaceuticals. I don’t see how Nuedexta’s pharmacological properties might control affective outbursts (but then again, I can’t explain precisely how SSRIs treat depression, either). Certainly I’ve read of isolated cases in which Nuedexta has led to “dramatic improvement,” but those cases are from spokespeople with “skin in the game,” so to speak. Nuedexta might be a blockbuster drug in neurology and psychiatry alike, and I’m willing to give it that chance. However, at this stage the marketing speaks far louder than the data, and the seeds are already being sown for the more widespread use of this relatively unproven agent. We need to be cautious not to be swayed by the influence of those who want to make a few bucks (or a few billion) off our ignorance.
Thought Broadcast 
Well spotted.
Apart from anything else dextrometh and quinidine are both long off-patent and I bet you could buy them in bulk from a pharmacist or chemical company for about $100 for a lifetime’s supply…
You can’t The Dextromethorphan Distribution Act
CHPA supports legislation ensuring that only legitimate entities registered with FDA or relevant state agencies can purchase raw, unfinished dextromethorphan, the most dangerous form of the ingredient when abused. Currently, there are no national sales or purchase restrictions for dextromethorphan in this form. The Dextromethorphan Distribution Act (H.R. 1259) was passed by the U.S. House of Representatives on March 31, 2009. CHPA is working to see that a companion bill is introduced and passed in the Senate as well.
The Dextromethorphan Abuse Reduction Act
CHPA supports legislative and retail efforts to implement sales restrictions prohibiting the sale of OTC cough medicine to minors. In the 111th Congress, the Dextromethorphan Abuse Reduction Act (S. 1383) was introduced to accomplish this goal. CHPA, and partners such as the Community Anti-Drug Coalitions of America, the Food Marketing Institute, the National Association of Chain Drug Stores, and the Partnership for a Drug-Free America, are working with members of Congress to see the legislation enacted.
FYI, that was never passed. Died in the house.
I think you are distorting the trial results when you state that, “the trials which led to Nuedexta’s approval showed only slight improvement vs. placebo in patients with PBA due to multiple sclerosis and ALS.” The actual trial results left no doubt as to efficacy:
“In 326 randomized patients (of whom 283, or 86.8%, completed the study), the PBA-episode daily rate was
46.9% (p < 0.0001) lower for DMq-30 than for placebo and 49.0% (p < 0.0001) lower for DMq-20 than for placebo
by longitudinal negative binomial regression, the prespecified primary analysis."
PBA can be a debilitating syndrome for those affected by it, and Nuedexta offers noticeable improvement within days for most patients. 50% of the patients in the study experienced complete remission.
Recent surveys indicate that PBA has been underdiagnosed and is much more prevalent than previously thought:
http://www.biausa.org/AnnouncementRetrieve.aspx?ID=63586
http://www.eurekalert.org/pub_releases/2010-10/s-nsa101510.php
http://www.msassociation.org/news_center/article.asp?a=_msaa_survey_pba
Andy,
You are correct in your quote of the primary results from the Pioro et al paper. I invite readers to view the results, particularly Figure 2. Please also note, however, the very similar CNS-LS curves (also shown in Figure 2) between D/Q (at both doses) and placebo.
Despite statistical significance of the findings you quote, the placebo response rate was quite high (remission rate was 30% on placebo – see figure 4), which is surprising for such a debilitating neurological syndrome. Also, the more relevant comparator is not placebo, but other agents that have proven to be effective in PBA, namely SSRIs and TCAs.
Nuedexta was one of only 21 drugs to be approved in 2010 by a very conservative FDA, based on the study in question, and it is the only drug ever approved for the treatment of PBA.
Its not unreasonable to try an older therapy and use Nuedexta as 2nd line therapy. However, critical examination of the evidence for those older drugs “proven to be effective” shows small studies with varying methods and likely high publication bias.
Subgroup analysis in the STAR trial showed that those on already on SSRIs during the study had the same treatment impact of Nuedexta as those not on SSRIs.
Past dissatisfaction with older therapies with conversion to Nuedexta suggest it is more effective. However, until better head to head data is available 2nd line use remains reasonable. More important is a screening of patients to find the ones with PBA that have been missed…this is the key to optimal treatment of your patients who often will not volunteer PBA issues.
If I run across this relatively rare syndrome as a consulting psychiatrist, I’d probably be more comfortable combining a low dose of Prozac, another potent 2D6 inhibitor, rather than quinidine, in combination with DM and possibly also get the additional benefit conferred by using an SSRI.
Be careful, both Prozac and DM target SERT receptors. Your experiment may result in unduly high rates of serotonin syndrome.
No other 2D6 inhibitors approach the potency of quinidine so activity may not be sufficient at clinically utilized dosages.
Blocking SERT with 2 different medications is unlikely to cause serotonin syndrome. We do it all the time with treatment resistant patients (e.g. clomipramine combined with an SSRI) and when cross tapering between 2 antidepressants. We even have many patients in our clinic taking tramadol with SSRIs without any problems. Ziprasidone also has weak SNRI activity and we have no problem combining it with SSRI antidepressants. You are only likely to get a serious serotonin syndrome when you combine an MAOI with a medication that blocks SERT.
You mentioned that PBA is relatively uncommon, yet in the article you pointed out,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1963355/
It clearly says that
“the prevalence of PLC vary from 7% to up to 48.5% of stroke survivors, with a greater prevalence found in inpatient populations and during the acute post-stroke period”
Exactly… those prevalence figures sound high, but they’re highest only in the acute post-stroke period. In other words, PLC (i.e., PBA) is best considered a transient symptom of some neurological insult, rather than a chronic syndrome requiring long-term medication; these cases are quite rare.
To me, it sounds like disease mongering at work.
Nevertheless, the “symptoms” of PBA are nonspecific enough to capture a potentially huge market– i.e., not just neurological patients, but a wide range of psychiatric conditions as well. And this seems to be where Avanir is looking to make its presence known. As a matter of fact, the Avanir booth at next week’s American Psychiatric Association conference is roughly the same size as those of Eli Lilly, Astra-Zeneca, Merck, and Bristol-Myers Squibb. And this is for a company whose drug has no psychiatric indication. Yet.
Disease mongering?
MS association did a 5,200 person survey and found that 48% of people responded with PBA.
http://www.msassociation.org/news_center/article.asp?a=_msaa_survey_pba
With all due respect Sir, your comments are fear mongering and not considering the real facts that are out there.
The prevalence of post-stroke PBA must first start with a definition of PBA. If you start with a CNS LS score of >13 then there about 26% nonacute post-stroke survivors have PBA (21.7% mild = CNS LS <21).
The Natl. Stroke Assoc. survey mentioned above (link to full data below) shows a significant impact on the lives of those affected. An attempt to unbias these survey data ( http://seekingalpha.com/article/260289-avanir-pharmaceuticals-uncovering-nuedexta-s-potential-part-i ) to get at clinical relevance of the CNS LS scores suggest that 1%/2%/10% of stroke patients find their emotional outbursts to be extremely/very/somewhat burdensome.
Point being, its not as rare as most physicians expect and dismissing PBA as "rare" without screening patients for it will result in suboptimal care for a significant portion of post-stroke patients.
http://docs.google.com/viewer?a=v&q=cache:UX2lMTWv5moJ:www.stroke.org/site/DocServer/NSA_PBA_Survey_Summary_Report_FINAL.pdf?docID%3D8081+NSA+pseudobulbar&hl=en&gl=us&pid=bl&srcid=ADGEESjzx2difNp_0V5g5NO_mWc7_io0jaowZI8ygCIV1B0HZeIzrqVjQYmEpX3pv3-07aWldnDw1HYKcBzSC5EoI7hCIsHUJ5g-Jk_0TipJfMqKjKkJLrlAX1BL2hFAZC_Y5ep6JrQr&sig=AHIEtbThbOHWWxoXbaCnYi5wr5O8pjoH6Q&pli=1
Well if PBA is such a transient symptom, I would imagine Avanir would have one heck of a time finding patients for its drug. What I read from available reports that Nuedexta is selling okay but its on the market for only few months. One would imagine if Nuedexta is a case of “disease mongering”, sooner rather than later physicians and patients like will realize that fact, and eventually get off the drug – after trying for few months. But on the other hand, if it improves the quality of life of patients then who are we to judge?
I am a geropsych NP who works in multiple SNFs and ALFs as a consultant. What I am finding in the SNFs are multiple orders for Nuedexta for patients in management of Schizophrenia, BiPolar d/o, depression, and dememtia with behavior s/s. As the state is coming down hard on SNFs for off lable use of anitpsychotics I am finding one of two things: 1. the patient is left on all their antipsychotic/mood stabilizing agents and having Nuedexta added and 2. All antipsychotic/mood stabilizing agents removed all at once and the patient placed on nuedexta. In the first situation I have found patient’s being hospitalized for heart rhythm problems d/t interactions with nuedexta and psychotropics and no proper testing being done (ie EKGs) and people suffering severe withdrawl reactions from being withdrawn from their medications suddenly. I have found that patient’s placed on nuedexta in any of these situations have declined rapidly. I have a patient that is schizophrenic, bipolar, and MR (Please note she does not have a dx or any indicators of PBA). She was placed on nuedexta and removed from her other drugs. She now wanders the facility in tears and actively hallucinating. I have discussed this with the prescriber and he states that the facility likes her on this drug because “her behaviors are controlled.” Who are we treating, the facility or the patient? I can tell you where this medication will be taking over and it’s sad.
a) Jennifer says explanation of costs are wrong.She doesn’t say how. If it doesn’t suit the hedge funds who are short 25 Million shares that’s not Avanir’s fault !!!
b) at least 1/2 the people who post on these kinds of boards are tied to hedge funds which are out to lose big because of their unethical actions trying to work against Avanir and the patients and medical advancement so they can pocket money.
c) the case geropsych NP described is extremely rare. Patients in general love Nuedexta and find great benefit from it.
I have been taking nuedexta for 6 weeks now and have noticed a huge improvement in my crying outbursts. this is the first drug that has helped me. I’m 46 and have suffered with pba for 30 years.
Please see my follow-up to this post:
I have been watching this drug very closely for a few years and hoping it would be approved by the FDA. My daughter has PBA as a result of a TBI in 1998. No crying..just inappropriate laughter. Her neurologist prescribed it..however…Medicaid will not pay for it and Avanir will not assist us in this matter. I’m hoping for an affordable generic soon. Any comments from current users of this drug would be appreciated.
I am disabled, Medicare, Medicaid Title 19 straight and have not let them railroad me into one of those HmO’s. In Wisconsin, my Medicaid pays for Nuedexta and I even take 3 a day. My added supplement D medication coverage Is Cigma. I 1st paid $3.40, for 30 days of Nuedexta until July when I no longer pay anything for my meds until the new year. Maybe if you get a supplement D medication coverage, you have to really look at what meds they cover, you should be alright. I had undiagnosed pba for 10 yrs. Nuedexta was a miracle, but it seems if you take another med with it, it can stop working. I hope this helped.
Hilary, it already IS available as generic.
Just get her doctor to prescribe 20 mg of dextromethorphan and 10 mg of quinidine, off label of course, but both available as generics.
Getting a doctor to prescribe generic DM and Q is not quite that easy because Q is not available in 10mg tablets. Thus, she will need to get it compounded. That in itself is expensive and not covered by insurance (though still less than the full cost of Nuedexta I’m sure). Added to that, compounding pharmacists are prevented by their own stated principles and federal law from recreating an available medication simply to circumvent marketing exclusivity. However, that doesn’t always mean you can’t find one that will do it.
I’m not trying to discourage an attempt to get the medication needed…esp. since Avanir won’t seem to help. Just pointing out its potentially not simple.
The patient can obtain DM from one compounding pharmacy and quinidine from another one.
I get it compounded cost is $90 for 60 doses. I use it for neuropathic leg and foot pain. It’s been very helpful
The Feds are now involved, asking Avanir to explain why they are charging so much for Nuedexta:
http://aging.senate.gov/hearing_detail.cfm?id=332984&
Thanks, Jackie. Yes, I had seen that story this morning too. (Here’s another link.) What bothers me about cases like this is that the government has to be the whistleblower, rather than doctors doing their own due diligence in inquiring about costs and/or other alternative treatments. Doctors (and sometimes patients too) have their heads in the sand much of the time, while drug companies take full advantage of our ignorance.
There are a lot of questions around timing of the inquiry by a few congress people. Just as the stock was heading to $5 which means a lot of mutual funds would qualify to buy which means the short cartel which has shorted 32 million shares and is out to lose hundreds of millions of dollars, Avanir get this inquiry. If anybody thinks there’s no corruption on Wall Street, that the large hedge funds who have journalists, analysts, brokers, even doctors in their pockets don’t have influence over politicians, then they’re dreaming.
Avanir spent millions and millions and many many years and developing testing Nuedexta. The passion behind it was to help those who have PBA and it was clear to them that Nuedexta helps with other conditions too. Every person involved in these trials had a genuine interest to get or give help. To summarize it all as just “intended to make money” is very far from truth. And I am one of those who thinks there may be a correlation between the inquiry by these few congress people and the short interest’s attacks. This was just another bullet in a series of bullets that short interest may have used to cap the stock to protect itself. These hedge funds are all about making money at any cost, not Avanir. These hedge funds have no morales. They lie like there’s no tomorrow. They misrepresent facts, they pay people to lie, and are willing to resort anything to kill small companies who are working hard to make the world a better place. Avanir has worked hard to survive in this very brutal environment to bring this drug to people who suffer, and the success stories we hear, are tremendous.
Kudos for a well written and balanced piece. As a neurologist I’ve also been on the receiving end of an immense and no-expense-spared Nuedexta marketing effort; but looking at things objectively there seems no reason not to first try SSRIs or TCAs which have been shown to be effective in non-industry-sponsored studies and for which there’s a longer record of safety and clinical experience. See below for a similar viewpoint by two psychiatrists and a response from the company’s medical director who proclaimed himself “disappointed” by the idea.
http://www.currentpsychiatry.com/article_pages.asp?aid=9577
They also raise the point that “Although DMQ is convenient, its advantage over starting with DM alone and adding a small dose of a nonserotonergic 2D6 inhibitor if DM is not effective remains to be demonstrated.” I’d go with Robitussin and tonic water, but that’s just me.
The active ingredient in tonic water is quinine, not quinidine. While the drugs are similarly spelled and both are metabolized by CYP3A4, quinine (tonic water) does not exhibit any inhibition of CYP2D6. http://www.ncbi.nlm.nih.gov/pubmed/12842189
Inhibition of CYP2D6 is necessary for DM levels to increase sufficiently to achieve the CNS activity necessary to reduce PBA symptoms. Therefore, drinking tonic water will not help increase DM levels.
Cimetidine is a weak inhibitor of CYP2D6.
400 mg of cimetidine orally every 6 hours could be tried to see if it allows 20, 30 or 45 mg of dextromethorphan every 12 hours to work as an attempt at a cheap alternative to Nuedexta.
One precaution people might not think of:
If someone were at particularly high risk of Tb you wouldn’t want to decrease their protective stomach acid with cimetidine.
quinine water is chemically a mirror image of quinine, it does not work the same
Correction (a mirror image of quinidine)
I was experiencing PBA to an extreme level, having ALS. I heard about Nuedexta and bought Mucinex DM which has a higher level of Dextrometh and there was no impact. Once I got the approval for the coverage on Nuedexta and started on it there was a direct and major improvement. However, the downside is that it has sucked my energy and is making me wonder if it’s worth taking because of the impact of my physical life. The other drugs I took had worse negatives, i.e. 12 hours of sleep daily, anger moments, and minimal effects on the PBA. So, will adding quinine water to Mucinex DM help? Paying $100 per month is not good, either. Thanks.
BJW, I think it is statistically more likely that the dextromethorphan in Nuedexta is causing your lethargy/fatigue, rather than the quinidine.
Hopefully the lethargy/fatigue has worn off by now and you are able to take Nuedexta.
As for the cost, Avanir Pharmaceuticals http://www.avanir.com
has a program that defrays copayments to something like $35 per prescription, at most. So I would contact them about eligibility for help with the copay. And a 90 day prescription lasts for 3 months so that would be less than $12 per month as opposed to the $100 per month you write that you are paying now.
On the chance that the quinidine in Nuedexta is making you lethargic or tired, you could ask your MD if it is advisable to stop the Nuedexta and try to take 20 milligrams of dextromethorphan with a Cytochrome p450 2D6 inhibitor medication besides quinidine but you would need to discuss this with your doctor.
Someone else wrote that quinine is not a Cytochrome p4502D6 enzyme inhibitor. If true, quinine would not help and quinine has possible side effects such that its use is discouraged.
Cimetidine is a weak 2D6 inhibitor, not nearly as strong an inhibitor as quinidine is. You would have to ask your MD if cimetidine is safe for you to try along with 20 mg of dextromethorphan twice a day. Cimetidine can be obtained cheaply, over the counter, without a prescription, but again, talk with your M.D. about it first!
Cimetidine can be taken 300 mg or 400 mg four times per day or the more convenient, 800 mg twice per day.
And of course you would also need to take 20 mg of dextromethorphan twice a day.
Cimetidine would greatly lower the acid in your stomach.
If you were at high risk of getting tuberculosis (i.e. you care for someone with Tb or live with someone who has Tb) lowering this stomach acid would be a concern.
Again, you would have to talk with your doctor about this. Only your doctor can practice medicine with you.
Best wishes,
Ray
Hi Ray, thank you for the response and suggestions. I did cut back on the dose just to see if that would help mainly since I have not taken drugs my whole life. Taking one dose in the morning is seemingly a balanced approach and manages the symptoms and still allows me to have energy and “normal” emotions. I did tell my doctor about this so that he’s aware and can manage his other patients, too.
Kindest Regards,
Brian
Sorry BJW, forgot to write that in the interest of full disclosure of any possible conflicts of interest, I own some stock in Avanir Pharmaceuticals and Avanir sells Nuedexta.
I started Nuedexta about 2 months ago. I have carpal tunnel. The highest severity in my right and also slightly lower in my left. It was keeping me up at night. I had so much pain I was dropping dishes and would have to take a break after just a couple minutes doing anything. I also started getting numbness and pain in my legs in the morning. I have ADHD and also depression. I suffer from left temporal lobe seizure disorder. On one occasion I had a seizure I fell and got a head injury dead center of my forehead. There was damage shown on SPECT scan. After Nuedexta the pain got 80 percent better in my arms. I am sleeping through the night. Finally. Pending another EMG to find out if the nerve damage is the same it is helping tremendously. It will be interesting if it changes. I just thought this personal information might be of use to someone. I cancelled my carpal tunnel surgery until I find out if my nerve has actually healed some or of it is blocking the pain. Thanks, Nicole
That’s very interesting Nicole. Thanks a lot for sharing your story which is another amazing story about how Nuedexta has improved quality of life. Best wishes to you.
Started Neudextra 3 weeks ago after taking Amytriptoline for 2 years. No sedating, no more adverse side effects from the TCA and I am writing again. I have had PBA for 15 years, I was diagnosed with motor neuron disease in 2002.
I have not had a PBA episode since the day I started Neudextra. I was having episodes daily while taking the TCA.
I find it interesting that whenever a positive comment about Nuedexta appears on this blog, it’s followed within a few hours by a post on the Yahoo Finance discussion board for Avanir Pharmaceuticals, with a link back to this page. Pumpers? Or honest commenters?
Webmaster, are you screening the comments on this board??
can capsule be opened and be taken wife has als and having hard time taking capsule
Carlos H,
It is an outrage what they charge for the drug. That being said, it works for me.
what is the cost?
It’s $350. for a month supply. Two very cheap generics combined.
The cost explanation is right. “Jennifer” who says shareholders are involved is a “short seller” who is so worried because the shares are surging because Nuedexta works and people love it. Take a look at these patient and doctor testimonials on http://www.avnr.info there are also doctor. There are also a number of articles and links to videos about it. The company offering the low co-pay is true. This whole line about “pure profit” “PBA is rare” “generics” is typical “short seller” argument. They use these bogus arguments because they do not have a good argument against the company.
If you ask yourself why there are such a huge number of shorted shares, the answer is historical. These guys shorted the stock blincly, for PURE PROFIT, and assumption that the launch will fail or that PBA is not real. All their assumptions have failed. Now all they have are these infrequently visited board to try to persuade a few people against Avanir. But the company will succeed nonetheless and patients’ lives will change for better because of Nuedexta.
Dear Jeff Tayloe:
Please realize that Avanir is charging what it’s charging because it has over two hundred million dollars of expenses in researching, making sure the drug works, and that it’s safe, and going through the legal processes of bringing it to you. If Avanir was a charity who would have funded this effort? I am happy it’s working for you. Please understand why the cost is what it is. If we expect companies to bring medication that help people to market for free then we can expect no more such medications is ever launched because this research is very expensive. Thanks for your consideration.
That explainatiion for the cost is wrong. There are Share-holders involved. It all has to do with PURE PROFIT. Whomever believes what you just said is stupid.
Could you not just take 20 mg of OTC dextromethorphan with a low dose bupropion to inhibit 2D6 instead of quinine? It should be no more dangerous than combining bupropion with SSRIs, which we do all the time.
I get it compounded cost is $90 for 60 doses. I use it for neuropathic leg and foot pain. It’s been very helpful
My pain management Doctor recently prescribed Nuedexta to me as an off label drug. I injured my back in 2002 and have non-stop pain which has been controlled by OxyContin and Skelaxin. I do not have any PBA signs, but have noticed in the last two months since I started taking Nuedexta I have increased fatigue; ringing in ears; double vision; excessive gas; frequent urination due to the constant feeling of a full bladder yet only void very little. I am concurrently taking Nucynta, Cymbalta, Clonazepam, Sulendac, Maxide, Provigil and Restoril. The Nucynta has replaced OxyContin as my primary pain reliever. I have been on permanent disability since December 2002.
My last four Doctor appointments have been focused on me attending a Rehab program to wean me off all the above drugs using ONLY Nuedexta. My Doctor wants me to attend the said program five days a week from 9am to 5pm. If I were able to awake each morning, get myself dressed and drive 30 minutes to a Rehab; theoretically, I would be able to work! I would absolutely love eliminating all my current medications. However, I can’t quite comprehend that taking Nuedexta will accomplish a “miracle healing” for my constant back pain, muscle spasms. Workman’s Comp has approved me to attend the Rehab program yet they refused to pay for the Nuedexta. My Doctor has been giving me a monthly supply of samples. I feel like I am being used as a “Lab Rat” because I do not have ANY symptoms associated with PBA. The only time I have burst ot crying in the last few years was from a pulled muscle in my back. I am now experiencing side effects since I started Nuedexta!
I look forward to hearing your input in this situation.
Thank You!
[…] memorable exchange was at the Nuedexta booth. Nuedexta, as readers of this blog may recall from a 2011 post, is a combination of dextromethorphan and quinidine, sold by Avanir Pharmaceuticals and approved […]
Nuedexta has shown to help with pain. Doctors have also been able to get their patients off several other drugs once they use N. The side effects might be due to taking too many things in combo so in principle it makes sense to get off the other meds and give N a chance. It has indeed been named a miracle drug but you have to see if it will work for you.
Por favor si alguien me puede ayudar, soy de Ecuador, he leido sobre la NUEDEXTA, para la ESCLEROSIS LATERAL AMIOTROFICA, a mi esposo le diagnosticaron ELA bulbal, y quisiera saber en que le puede ayudar, y en que dosis, le debo dar, cuales serian los efectos secundarios que se pueden presentar. Les agradeceria mucho que me ayuden con esta informacion.
The skepticism surrounding Nuedexta is understandable, but I want anyone reading this thread to know it worked wonders for me. I was diagnosed with MS about twelve years ago and recently had an exacerbation. Subsequently, I experienced depression, which is fairly common among MS patients, especially those coming out of a flare. A few months have passed, and I slowly felt better, but I kept experiencing episodes of crying, laughing, or reacting inappropriately to things people said or did. It was frustrating because I never had that problem before now. I was being treated for the depression and a recent MRI showed a couple new lesions on my brain. In any case, my neurologist tried a few different meds for me that did not touch these new symptoms. Once I told him my experiences, he seemed to think PBA might be the culprit. I too was skeptical about this new drug, but since using it, I feel in control again. Yes, I still have my down days, but nothing like the uncontrollable crying or outbursts that are contrary to my nature. And no, I am not a paid spokesperson. In fact, my insurance company fought not to pay for Nuedexta.
My husband is a tbi to the right frontal lobe, 4 months ago we went to a psychiatrist for depression. which was caused by an event that he just wasnt getting over enough he had an actual violent episode over it. She turned us toward nudexta telling us it was a new drug for thiese exact symptoms and she thought it could help. the first 2 weeks he seemed great. but then he beame extremely fatigued so much that after a full nights sleep he would get up and 2 hours later need a nap His focus became awful and his irritability level sky rocketed. He also started getting extremely dizzy. So he cut back to one a day. When that didnt work he tried taking caffine to keep himself awake all the while his irritability level grew. So 1 week ago he decided to stop taking it all together. In one day he was perfectly normal and happy. He stayed up all day and not one sign of irritability at all. He has been doing wonderfully since. But I not being able to get his psychiatrist to answer my calls. went to look up nudexta. what i want to know. From what i think i understand that pba only has to do with the emotions of laughter and tears? If so, he has never had that problem just some anger due to his frontal lobe injury.
Can anyone clarify this please. I cant find it in my judgment to make him take it until I understand it more. especially when i have to pay 585 for the medicine itself.
I’m being courted into joining a clinical trial for MS related pain.
I’m a little concerned by the common side effects such as lethargy and dizziness.
I’ve been trying to find reviews from others using N for MS related pain, but there’s just not a lot of information out there.
I use other drugs that are contraindicated with the use of N and fear that I may end up in a worse situation as they will require me to stop other medications and flush before trying N – that is if I am lucky enough to get the actual drug instead of the placebo.
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I took the PBA test at the National Stroke Association website and I answered all questions “happens rarely”, resulting in a score high (14) enough to provide this result “A score of 13 or greater may indicate you have PBA.”
Thank you for this information. I was recently diagnosed with MS and was put on Nuedexta after taking the test. I could have answered that test differently any other day, but having it on the day I was told I had MS makes me feel a little uneasy. I was not put on any other medicine, just Nuedexta. I’m beginning to think that there is some benefit for my doctor and that I should really look into this before taking. Any thoughts from other MS patients? Is it normal to only be on this medicine?
I scored a 17, but like I said, it was a bad day.
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I would guess from your article that you are a physician and I appreciate your skepticism regarding this drug. I have found that a lot of doctors push certain drugs and I’m sure that’s financially driven. However, in our case, Nuedexta has been life changing.
My husband has Intermittent-exacerbating MS and over the years he has become challenging. Yes he tears up quickly over almost anything but that wasn’t the main issue. He argued even the smallest points, was accusatory, extremely defensive and lacked compassion. He showed no signs of affection and would get “stuck” in a down mood for days or sometime weeks. When he recognized that he was stuck, we went to the neurologist. He prescribed Nuedxta and life change within days. He’s the man I married once again. He’s sweet, kind, loving, funny and easy. Like he used to be. He does not remember how challenging and difficult he was. He does know that the tearing up has gone and he is grateful.
He was in the hospital recently with kidney issues. They took him off the Nuedxta for a couple of days and he was right back to his less than pleasant personality. The kidney issue is that we can’t get his potassium to stay down. We are suspect that it’s the Nuedexta. Working with Nephrologist and Neurologist to solve the puzzle. If he has to go off of this drug I will be devastated. I can’t even begin to explain how this will effect him, me and our 30 year relationship. I don’t think there is a replacement drug.
Just thought you might want this information for your research.
Regards,
Kathy
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[…] Nuedexta: “Pipeline in a Pill” or Pipe Dream? | Thought … – If you’re like me, you’ve probably seen numerous Internet ads for a new medication called Nuedexta from Avanir Pharmaceuticals. Nuedexta was approved in October … […]
Just throwing this in there…but some slight attention has also been paid to dextromethorphan for fibromyalgia pain and possibly the often accompanying chronic fatigue. Having fibro myself, I have guinea pigged on my own behalf, as it is otc and fairly easy to get. It does have a quite significant positive effect on both the pain and fatigue. I’m a bit concerned about the brain damage, of course, so I am going to do a short trial. However, I do see myself getting many more things done recently. I have a son with autism as well, which suggests that there could be a problem the two of us share. I am speculating. But it does make me feel less fibro foggy, and improves my ability to get things done. I am certainly no junkie, but the medical establishment has utterly failed people like me. I also have chronic pain that adds to the fun, but there’s a horrible stigma with unseen illness.
I was in a car accident and had a concussion which led to cognitive therapy and a diagnosis of pba. Previous to this I was diagnosed with ptsd, been suffering with bouts of depression ever since, antidepressants never did much. I started nudexta was on it for awhile and felt better, except for the constant headache. I stopped and I’m pretty depressed, I will probably go back on it, would rather deal with headaches than feel the way I do.
I will say this to the medical profession, and let them evaluate. Dextromethorphan, properly delivered to the system in just the right dosage, is an anti-depressant the likes of which medicine has never before seen. If combined with other drugs to regulate potency and rate of delivery to the brain, it can relieve the most obstinate depressive mood within hours! If delivered to a person contemplating suicide, that person would be of a changed opinion and in a good mood within one to two hours. This must be looked into.
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Well written and intersting article. I am a caretaker for a person, 88, recently diagnosed with Parkinson’s. The neurologist took her off wellbutrin (PC) had rx’d and after being stabilized on Cinemet, he rx’d Nuedexta. The cost prohibitive, but her insurance covered 2 thirds of the almost $900 cost and a special program the rest. The authorizarion was only for 3 months. I did not realize it so she missed almost a week of doses before it was re-authorized. The difference in her is amazing between taking Nuedexta and not. The PBA came back in full force by the end of the week.
It has made a huge difference for her. Yet the cost is so prohibitive for many, how many will it really help?
My 93 year old mother was placed on Nudextra. She was crying some at being moved from assisted living to a memory center in a nursing home. She started the Nudextra and I am so very afraid for her. She had a leaky heart valve and irregular heartbeat already. She was taking Detroit for sluggish bladder. She has gone from being able to converse normally to non conversave at all. Her eyes look like a blind person and she is cold with shivering all the time. Her throat seems to just not work and her brain seems unable to formulate more than two words. She has stopped walking at all. Wheelchair, now. She is dizzy, lightheaded,low respiration rate and now swelling in both feet to the posing the skin is breaking and she has vasculitis. Her mouth is dry and she prefers sleeping all the time. I asked for a reduced dose but was told the full dose or none. The changes have all occurred in the 80 days she has been on this horrible drug. She is trapped inside and attempts to talk. Her eyes show a desperation to speak and be understood. I requested today, if the dose cannot be adjusted, for it to be decreased. I think this is laziness of caregivers and a great way to have a compliant patient. If the request is denied, I will attempt to find a different nursing home. The physical side effects are too great. She has not had one test, nor EKG, nor were any other drugs tried. I would appreciate any feedback. Thanks, Penny Sanders
Detrol not Detroit. Correction in above blog.
I was just given samples from a doctor/chiropractor’s office post-concussion in a car accident, i’m skeptical about any drug, and take as little pharmaceuticals as possible. only one daily. i’ve always been a passionate, very sensitive person, and cry easily. i haven’t noticed a large increase in crying since the accident. but they said this will help mediate my emotions, and that brain injuries sometimes result in neurochemical imbalances that affect emotionality. ok, that can make some sense to me, but i’m still skeptical. anyone else prescirbed it for a concussion?
i prefer to do things naturally, and upped my dose of high quality fish oil supplements, and ‘brain foods’, and drinking plenty of water.
My husband is a Traumatic Brain Injury (TBi) patient who has presented with Grand-mal seizure disorder and severe ADHD. In 2014 he had a right temporal lobectomy to correct the seizures and although they did not expect the surgery to work, so far it seems to have. The problem is his attitude and mood stability changed dramatically. He was prescribed Neudexta along with Invega to help with the mood instability and inability to decipher social cues (including spontaneous action that were attracting the attention of law enforcement) about 6 months ago. Since then, as long as he takes his meds properly, his attitude and behavior have changed dramatically! I have the man back that I married 14 years ago. Our lives have been a roller-coaster with him but now, finally, I can talk with my husband and it is truly him that I am speaking to and not the effects of his condition.
I know that the cost, for now, is high financially but I will do everything possible to make sure he continues to get this medication as it has changed his life and the lives in our family for the best! I would recommend this medication to anyone who has not found a suitable mood stabilizer that has a TBi!!!
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Would combining extromethorphan with propranolol have a similar effect or does propranolol work by a different mechanism?
Thanks for this honest opinion of Nuedexta. I have a developmentally disabled daughter who is non-verbal and diagnosed with catatonia. She has been prescribed Nuedexta because it has been shown to help with catatonia. That is what I have been told. Few medications help with this condition. Currently taking Ativan and receiving Electroconvulsive Therapy. After reading patient reviews which seemed mostly negative I will still give this medication a try but I am glad I found this background information.
I couldn’t agree with you more. I was prescribed Neudexta by a psychiatrist I started seeing because I had a car accident and diagnosed with traumatic brain injury. After the injury, I became very depressed, an emotional wreck, absence seizures, crying spells, etc., Coincedentally, my Neurologist had never received information on the drug. Talk about prescribing out of indication.
The good news, I started taking Neudexta and experienced almost overnight a positive change. The medication then cost me roughly $120.00 per month w the copay
Cards my pharmacy utilized.
As of January 2018, these coupons are no longer available for neudexta, so the cost for me will be around $749. per month…crazy. I am permanently disabled. I’m on 11 different medications and the one I really need Neudexta, I can’t afford.
I called Avanir to see if they had any assistance programs they could offer. I was treated like a non-human., just awful. Supposedly some paperwork is coming via mail and many hoops must be cleared before Avanir decides if I get to win the “Neudexta Lottery.” Additionally, the customer service representative asked me very personal information after getting my name, address, etc., (Can anyone smell HIPPA Violations)?
Now, I’m researching alternatives to Neudexta. Hummm, maybe I should start a company who makes only generic versions of these “rip off” “me too” drugs. Yes, Neudexta is protected for seven years under patent, however, the way around patent is change one tiny part of the parent compound, conduct a clinical trial with just 20 patients on drug vs placebo and bang, we get FDA approval. Trust me, FDA and private insurers as well as Medicare and Medicaid have skin in the game of getting generics approved asap. So, if you are a “ME TOO,” and I’m not referring to sexual harassment, I’m talking about being price coughed by Pharma companies, join the band wagon. Let’s all pitch in and start our own generic company. Actually, I have a better idea, let’s hedge our bet and put a short sale in on Avanir, so when it’s stock hits rock bottom, we will or I will be a billionaire and use my profit to save Americans from losing everything just because they had an accident, or they have an orphan disease, etc. I for one, am going for it! Bye, bye
Neudexta, may have a brain injury, but I’m your worst nightmare. What I know about the criminal activities that go on within the pharmaceutical industry can and will be utilized so you lose and I win. Please feel free to cut and past my response and share it where you like.
I was prescribed Nuedexta by a neurologist 6 months after my stroke. The doctor didn’t even bother to ask me the simple 13 question to determine if I had PBA. He just gave me some free samples and asked me to come back in 5 weeks to see how the pills are working. When I got home I did some research and the more I read about PBA, the more I realized I don’t have it. The more I read about Nuedexta, the more I realized I don’t want to take it. The drug also interferes with Metformin which I take for diabetes type 2. The doctor said he’d work with me to get Nuedexta covered by my insurance, but it’s not the cost I’m worried about, it’s taking a drug for a misdiagnosis that scares me. A lot of side effects too to Nuedexta. I’m getting a second opinion and seeking a new neurologists. My overall impression of the doctor handing out free samples of Nuedexta is that of a street corner drug pusher, give them a little taste of the drug for free and get them coming back as a regular customer. No thanks. I’ll go another route.
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Although knowing that there is a “meth” in the word dextromethorphan made me suspicious and a bit fearful of this drug, my Nuedexta prescription has played a key role in helping me to remain in my career. I have progressive multiple sclerosis with associated and unfortunately significant brain atrophy. Over the past few years, and increasingly so, I found myself wailing almost uncontrollably at the slightest hint of a sad situation (even during the sad(ish) parts of a Disney cartoon). As one of the management leads of my project, I was required by tradition to give a speech at a retirement party of a colleague. I sobbed loudly while delivering this speech for a person whom I didn’t even regard as a personal friend. Things got so bad that I had to just start avoiding being around people because I would always end up crying. This behavior was in stark contrast to my former typical personality — I was never a “crier” before. After my neurologist prescribed Nuedexta, I am able to hold no-tears conversations and behave in a professional manner with my colleagues again. For me, this prescription is absolutely worth its price — it has helped me be around people again without fear of looking like a sobbing mess. My only concern is developing some kind of dependency on the drug, so I take it sparingly: on days when I know that I am going to be interacting with colleagues and/or know that dealing with the day’s agenda will require some additional emotional fortitude.
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Thank you for your take on this. I would love to be in contact with you.
-Nathan