August 10, 2007

New Bifeprunox Medication Not Approved by FDA

Bifeprunox, a new medication that until recently was viewed as the next one to be sold for treating schizophrenia, was rejected by the US FDA this week.

The U.S. Food and Drug Administration concluded that effectiveness data for bifeprunox were not sufficient for approval when compared with other drugs, Wyeth, the main pharmaceutical company representing the drug, said.

The companies that developed the medication said Friday that they had received a letter from the Food and Drug Administration (FDA) saying the drug was not as effective as current drugs. In a conference call they said one person had died during studies for the drug, and the FDA had sought greater clarity on this. The cause of death was multi-organ failure Wyeth said.

The global antipsychotic medications market size is very large and was about $18.2 billion in 2006, according to pharmaceutical market research firm IMS Health.

Just last month we featured a news posting on bifeprunox's promising results in their phase III drug trails. Many researchers are professionals had been hoping that this drug would be one of the drugs to help treat schizophrenia and psychosis without the high risk of serious side effects.

But during one of the clinical trails, a patient died while participating. Now the FDA is requesting more information on the human metabolism of the drug, and trying to understands if bifeprunox was to blame. People representing Wyeth have said that "the patient who died did so during a trial examining bifeprunox for acute treatment of schizophrenia. They said it was a complex case and that the patient was on bifeprunox." They continue to say there are no safety issues.

Overall the lack of approval stems from the drugs inability to perform as well or better than the current medications for schizophrenia. Even though there are less side effects, bifeprunox is less effective. And the company acknowledges that no physician will switch medications from one that is working to one that may not work as well.

Wyeth has said that one standout for bifeprunox is it does not cause weight gain. Despite reports it caused nausea, in a conference call Friday the companies said nausea was not a prominent concern

Wyeth suggested that it may be able to "gain approval for bifeprunox for the long-term maintenance of patients with schizophrenia." But there will need to be more investigating into the effectiveness by the FDA before that can occur - estimating at least 1 to 2 years.

U.S. Deems Wyeth Schizophrenia Drug Not Approvable New York Times (Free Registration Required)


Jeez..a guy died from multiple organ failure whilst on it...remind me not to be a guinea pig for any medical trials will ya?

Posted by: Salty Dvis at August 10, 2007 01:28 PM


Unfortunately its impossible to know whether the single death was due to the medication, or some other condition that the person might have had. Virtually every medication on the market today has people in their trials who experience medical difficulties, and in many studies (which can include thousands of sick people) someone dies - but that doesn't necessarily mean the medication caused the death. More research is needed - and it sounds like the FDA is requesting that, and requestion more information.

Posted by: szadmin at August 10, 2007 02:00 PM

It is a b-med compared to existing meds, to release it on the market is not a step forward but a step backward

Posted by: Joyride at August 11, 2007 07:57 AM


I guess Wyeth should do there research in the Western Hemisphere, like the United States and Canada. The think Abilify is some what better when I take Fish Oil daily and eat rice.
It probably would help if Weyth did not police the patient, but provided a wider selection of consumer friendly Bifepunox tablets, this is the United States.
A partial antagonist for dopamine may have potential, but either the selective 5HT science is too good in blocking dopamine or not quite wide receptor enough to be potent.
Wyeth probably was rejected because of coffee drinkers, and nicotine addicts. The drug probably is only active in the body less than 5 or 6 hours. Try an extended release 8 hour bifeprounox.
Avoid vitamin fortified cereal I think with today's very selective neuroleptics, the uneven distribution of vitamins in large bowl of cereal can be a long term factor in the production of dopamine. I willing to guess that vitamin fortified cereal is more a factor in its affect on patient stabilization than a couple cups of coffee when a neuroleptic is taken on a daily basis.
Serotonin interplays with coffee, and nicotine.

Posted by: Ken1 at August 11, 2007 12:48 PM

Its dissapointing, I was very much hoping that this trial drug would be ideal because of its good metabolic profile, but if it was found to be not so effective compared with the existing drugs then no good.
They can certainly modify it and we can still look forward
for a better outcome. After all, many current atypicals
have huge metabolic issues and patients would ultimately have premature death from Diabetes and heart disease. so, hopefully trials could continue with drugs with good metabolic profile.

Posted by: jena at August 13, 2007 03:39 AM

So now the company has to do more trials. If the trials work out then the company has to apply again. It will be at least 2010 before this med could possibly be approved.
Nothing else is pending with the FDA now.

Posted by: Robert at August 13, 2007 10:51 AM

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