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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Last reviewed: By John M. Grohol, Psy.D. on 10 Aug 2007
Published on PsychCentral.com. All rights reserved.
Grohol, J. (2007). Wyeth Schizophrenia Drug, Bifeprunox, Suffers Setback. Psych Central. Retrieved on February 13, 2012, from http://psychcentral.com/blog/archives/2007/08/10/wyeth-schizophrenia-drug-bifeprunox-suffers-setback/


Dr. John Grohol is the CEO and founder of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.