Thursday, February 20, 2014

Why is Forest Laboratories discontinuing Namenda?


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

12 comments:

Bruce Scott said...

I think this makes a perfect opportunity to stop Namenda prescriptions.

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.

Bob Pike said...

You should really do at least a little research before slamming someone...anyone. Namenda IR and XR both go off patent in early 2015. The XR switch is to get patients ready (and make FDA approval easier) for the FDC of Namenda XR and Donepezil that has been in the works for several years now:
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

Eric Widera said...

I am not a patent expert, but I did do a little research into this before publishing. Here are some links to articles that make a clear point that Forest is not going to back down on maintaining non-generic status to Namenda XR until at least 2016.

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

Eric Widera said...

Bob,

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.

Jim Mittelberger said...

Of note, Namenda XR 14mg is twice the price of Namenda 10mg at approximately AWP of $10 per pill vs $5.50 . Are there data comparing the efficacy of the two formulations? Given the challenge demonstrating a clinically significant effect, it seems unlikely.

Anonymous said...

The 10mg is a twice per day med...so xr is actually $1 less expensive per pill.

Eric Widera said...

Until of course it goes generic then the 10mg pill will be a whole lot cheeper

Anonymous said...

My mother is in an A/L facility and in December she was switched to Namenda XR without our knowledge. Supposedly the pharmacy told the doc to make the switch. Her personality changed, she fell asleep at the dinner table and she fell out of bed--all in the first month. When we found out, we switched her back to 2X/day 10 mg and she returned to her normal self. It's disgusting that Forest Labs is doing this for profit motives. Come August, only the oral suspension will be available for the 2X/day, 10mg dose, and her copay would increase 75%. We plan to simply DC the Namenda if that is her only option. Euthanasia is needed if this is how our elderly parents are to be treated by the greedy drug industry!

Dave in Maryland said...

In all of the comments about the ineffectiveness of Namenda, I don't see anything about prescribing it for off-label use. I've been on it for five years for multiple, daily migraines I'd been having for decades. No other medicine or procedure helped. Since I was prescribed Namenda by the head of a Headache Clinic at a major university, I've had only about three migraines in five years and they were relatively mild.

Anonymous said...

I'm curious to know how Forest Labs determined that the a single dose of Namenda XR was equivalent to traditional Namenda dispensed twice daily. I'm no math wiz,but Iknow that 28 does not equal 10x2.

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.

Anonymous said...

We wait for the day our drug goes generic and the billion dollar industry finds an avenue to keep collecting billions the most outrages thing is the contracts created with Medicare our co-pay and drug charge are charged to Medicare. Such a sweet deal for many pharmacy's and the drug companys if you don't shop for the best price, donepezil at Costco 27.00 for 90 days,(no insurance) donepezil at Sam's 118.00 30 days (charged to Medicare), I called and they said that Corporate office prices, they must have a sweet contract. Isn't this robbing Medicare? I'm a care giver to both my folks they are both 89, how on earth can they shop for a fair price for drugs at this stage of their life. I will have a talk with my Mom's MD concerning Namenda which she is currently taking along with donepezil. I really question 28 mg replacing 10mg twice daily. How safe is 8 additional mg's. We are at the mercy of the drug company's and many pharmacy's!!!

Anonymous said...

Agree 100%

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.