May 07, 2009

FDA Approves New Antipsychotic For Schizophrenia

The FDA yesterday approved Fanapt (iloperidone), an atypical antipsychotic made by Vanda Pharmaceuticals, for use in the treatment of schizophrenia in adults. I don't know a lot about this drug--it's the first antipsychotic given its initial FDA approval in years--but what I do know gives me cause for concern.

First, last year the FDA issued a not approvable letter for the drug, so there was clearly something wrong about the safety and efficacy of Fanapt at that time. What exactly we're unlikely to know, since the FDA won't release non-approvalable letters and there's little chance of the company doing so. What changed between then and now with the drug and its performance I cannot say.

Second, I strongly suspect that the drug will quickly be repurposed for use in other disorders, possibly even off-label. That's been the pattern with the atypicals over the last 15 years--get a schizophrenia approval, then a bipolar approval, then market the hell out of it off-label for everything else under the sun. There's little reason to believe that things will be different this time out, especially since the patent application for this compound clearly states that it's intended for the "treatment of affective and attention/behavioral disorders."

So maybe Fanapt can grow up to be like Zyprexa, Seroquel, Risperdal and Abilify and be used for absolutely everything from ADHD in kids to schizophrenia. We shall see. I can assure you I'll be watching this drug closely. Its patent expires in 2021.

The financial markets sure liked the news: Vanda's stock price reportedly exploded 824 percent higher in after hours trading.

Posted by Philip Dawdy at May 7, 2009 12:05 AM
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Comments

I feel like puking after learning this news. As I was reading the collum I wondered if the price of Vanda Pharmaceuticals was going up. Jokingly thought one should invest in the company. 824%, 8 times your money now. Psychiatry is legal slavery. Did you have the news of drug approval before the stock market knew? Financial Investors (psychopathic) should be reading this website to know when to buy and when to sell their pharma co. stocks.

Posted by: mark p.s.2 at May 7, 2009 04:33 AM

What changed is the medical reviewer who turned down iloperidone was forced out of the Psych group a few weeks later.

Posted by: xxx at May 7, 2009 07:57 AM

This drug has been investigated since the early 1990s and changed hands several times. I am unsure why Novartis was not able to bring it to market. Usually when a promising drug has undergone multi-million dollar trials and subsequently not made it to market, there are either failed trials (lack of efficacy) or safety concerns. The path of iloperidone to market has been extremely atypical. I suspect that the manufacturer has been trying to walk the tightrope of getting the lowest possible doses into labelling in order to minimize disclosure of tolerability or safety concerns. This is just my speculation, time will tell.

Given the early development and its long history, I wonder just how much patent life there is left in this medication?

Posted by: Daniel Dugan at May 7, 2009 08:48 AM

Philip - I'm on it. I'll be searching PubMed for you and doing my best to decipher what I am capable of deciphering (I'm no psychopharmacologist, nor doctor but I have done a lot of self educating and taken a few classes). If I get any abstracts that are written in understandable english I'll pass them along. If I find anything that looks fishy to me I'll post it here in the comments on this post and maybe someone who's more edumacated than I can tell us all exactly what the heck the people writing the abstract are talking about.

Posted by: katielou82 at May 7, 2009 10:07 AM

Part of the initial rejection, I think, had to do with Vanda's attempt to pair the medication with a genetic testing protocol to determine if a person was likely to respond to it. That, and the fact that it was not as efficacious as Risperdal. It seems that the approval was along the lines of "well, at least we have another medication to offer." All the same side effects as the established atypicals. Old wine in new bottles.

Posted by: Dark Jay at May 7, 2009 12:02 PM

Fanapt?
I guess they did a terrible choice.
Fanatic.

It may sounds silly but they really spend time trying to find the right name and to make it more scientific uses X,Y and Z a lot:
Prozac, Zoloft, Zyprexa, Abilify...

The financial markets sure liked the news: Vanda's stock price reportedly exploded 824 percent higher in after hours trading.

So everything is great. When we finally accept that these are the people these drugs are created for we will be at peace.

Dear Lord!
People are dying I said DYING, committing HOMICIDES and SUICIDES - even children - under these drugs.

THEY DON'T CARE.
Stakeholder and Shareholders are the master of the world.

I'm sorry for saying the obvious but some people come here for the first time.
I received two comment that made me see how far people are from knowing these data.
Sometimes raising awareness means writing as if you just started to discover it.
I don't remember but I'll make an effort to try to remind the feeling of the first suicide I became aware.

Posted by: Ana at May 7, 2009 01:07 PM

Existing anti psychotics are going generic .. they need a new cash cow ... fanapt is a joke

http://www.thestreet.com/story/10497618/1/surprising-approval-for-vandas-fanapt.html

Posted by: Kevin at May 8, 2009 12:10 PM

also dont forget that Obama's FDA Commissioner is due to be appointed soon... they got this out of the way before that ... the greedy neocons probably making money by drugging children ...

Posted by: Kevin at May 8, 2009 12:44 PM

This is just another disgusting filthy toxic compound that governments are going to force feed to distressed... and label them with pysch labels, and poison the hell out of them. It's neurological vandalism, pure and simple... fucking with neurology, without any diagnostic biotechnology, it's pathetic, an embarassment to medical science, it should be condemned by all members of pure medicine.

Posted by: Andrea Stout at May 9, 2009 09:42 AM
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