Why is Forest Laboratories discontinuing Namenda (memantine HCl) 5 mg and 10 mg tablets on August 15, 2014? Is it because there were no significant benefits of the combination of donepezil and memantine over donepezil alone in a study published in the NEJM in 2012? Maybe, just maybe, Forest Labs is discontinuing Namdena because even the most positive trials of Namenda show only a very small statistically significant benefit that may very well be clinically insignificant? Wait, I know. Can it be that Forest is discontinuing Namenda 5mg and 10mg tablets because they are worried that individuals are being prescribed this medication earlier in the course of Alzheimers despite the fact that memantine is only approved for moderate to severe disease and despite a growing body of evidence that it provides no benefit in this population of patients?
Sadly, Forest Laboratories is discontinuing Namenda mg and 10mg tablets for none of these reasons. They are discontinuing it because Namenda is going off patent in April 2015. This means that a host of low cost generic memantine will flood the market and replace non-generic Namenda in a year's time.
So how does a pharmaceutical company maintain market share when competing against low cost generics? Well the good folks at Forest have decided that if they can just move everyone who is currently taking Namenda to Namenda XR (the extended release version of the drug), they won’t have to compete at all, since there is no generic version of Namenda XR.
So what will patients experience? When they try to fill their prescription for Namenda 10mg BID come August 15th, they will be told that their twice a day pill is no longer made and will need to get a new prescription for Namenda XR. Brilliant!
This tactic is called a “forced switch” and has been attempted with other drugs in the past that were going off patent. There is a catch though. The little wrinkle in Forest's plan is that someone needs to write that prescription. My recommendation is that we should use this time to reconsider the merits of continuing to prescribe Namenda in any of its formulations. For those with mild dementia, the evidence is clear that we should just stop it. For those with more severe dementia, it definitely warrants a talk with the patient and their family members about whether there is really any benefit from continuing a medication that at best has shown to have only marginal benefits.
by: Eric Widera (@ewidera)
Note: a big thanks to Bruce Scott (@skipbidder) for the lead on this story. Also, check out this previous post on Aricept 23 to see how Forest isn't alone when in comes to deploying cheap tricks to increase revenue streams
Comments
All of my current patients on Namenda were started on the medication by other doctors before they were my patients. Most have families that are keen on continuing meds, often because they were oversold on potential benefits in the first place. This gives me a new reason to suggest stopping.
http://info.recap.com/rs/deloitterecap/images/Adamas_Forest%20Nov2012%20Deal%20Snapshot.pdf
This is not the same as when AR23 came out within months of generic donepezil being available.
If you question the efficacy of memantine that is up to you but, you sound ignorant when saying, "Forest Labs is discontinuing Namdena because even the most positive trials of Namenda show only a very small statistically significant benefit that may very well be clinically insignificant?"
I would not want my loved ones coming to you in need...doctor
http://www.gabionline.net/layout/set/print/content/view/full/3015
http://www.istockanalyst.com/finance/story/6633037/forest-laboratories-inc-frx-will-the-force-switch-of-namenda-xr-be-successful
http://www.nasdaq.com/article/forest-labs-sues-several-companies-for-infringement-of-namenda-xr-patents-20140131-00747
That first paragraph was meant to add a little sarcasm to the post. I'm sorry if it was lost on you.
Minus sarcasm though, I stand by the comment that all evidence for the effectiveness of memantine in moderate to severe Alzheimers suggests at best a marginal clinical effectiveness. For less advanced disease, the evidence states that it doesn't work.
My mom has been taken Namenda 10 mg. twice daily for about 5 years. I don't know if it's doing her any good at this point or whether Namenda XR will either. The only way to know is to take her off it. But I am afraid that if I do, her synptoms will accelerate.
I go to nursing homes and use these meds often, usually at the behest of family.
I've never (n=0) seen a single case where I thought they made any difference. There is nothing meaningful to measure their effect. It is a medication you may take for years without knowing it is having any effect.
A perfect example of a corporation succesfully promting a med over scientific and clinical evidence.
This was prescribed by one of the top rated pain clinics in the US.
They have not had a positive result when switching pain patients to Namenda XR.
Does anyone know if Namanda will remain available in Canada, or is it being discontinued there too?
1) Forest, nor any other drug company, can't simply make a drug like Namenda XR and have it available for doctors to prescribe. The FDA requires rigorous studies to be conducted on a drug before giving its seal of approval;
2) Regarding efficacy, NO MEDICINE FOR ALZHEIMER'S DISEASE HAS BEEN SHOWN TO *IMPROVE* SYMPTOMS. Clinical trials for Namenda, Aricept (donepezil), and CerefolinNAC merely demonstrate that patients who take these medications versus those taking a placebo will lose functioning at a slower rate. If you expect to grandma to suddenly start remembering forgotten memories, names, etc because she is taking one of these medications, then your expectations are out of whack. Unfortunately, SLOWING THE PROGRESSION of Alzheimer's Disease is the best that medical science has to offer right now.