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August 10, 2007
New Bifeprunox Medication Not Approved by FDA
Read more... Schizophrenia Medications
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)
Posted by Michelle Roberts at August 10, 2007 09:51 AM
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