The U.S. Food and Drug Administration (FDA) let Wyeth and its partner, Solvay Pharmaceuticals, know that their newest schizophrenia drug, bifeprunox, needed further research to gain FDA approval. Pharmalot has the story.
While the FDA acknowledged there was enough efficacy data to support short-term use of the drug (e.g., the drug works better than a sugar pill), it didn’t really differentiate itself from other existing schizophrenia drugs on the market.
According to the entry, this likely pushes back approval for the drug to late 2008 or possibly 2009. Assuming, of course, that the new studies continue to show similar positive data for bifeprunox as the existing studies do.
Here’s more information about bifeprunox.
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2 Comments to
“Wyeth Schizophrenia Drug, Bifeprunox, Suffers Setback”
This article is a brief relay of the facts. Where can I find more extensive info. on bifeprunox and what is required by the FDA for approval? Are there any other antipsychotic drugs in the making that do not have the side effect of metabolic syndrome? Is there a way to treat metabolic syndrome and still take the drug that causes it? Thank you. Rita Plazo
Information is hard to come by on this drug, as the FDA website still doesn’t have the action letter they sent to the drug’s makers on Aug. 9, 2007.
Bifeprunox, a partial dopamine agonist designed to normalize levels of chemical activity in the brain, has been studied in approximately 2,650 patients with schizophrenia at more than 200 Phase 2 and 3 clinical trial sites in the United States and throughout the world.
It now looks like they won’t have the data they need to meet FDA’s requests from the action letter until 2009 at the earliest. You might not see this drug on the market, assuming the FDA is satisfied with the company’s response, until 2010 or even 2011.
Unfortunately, I don’t know the answer to your last 2 questions.
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