Comments on: Wyeth Schizophrenia Drug, Bifeprunox, Suffers Setback http://psychcentral.com/blog/archives/2007/08/10/wyeth-schizophrenia-drug-bifeprunox-suffers-setback/ Dr. John Grohol's daily update on all things in psychology and mental health. Since 1999. Mon, 13 Feb 2012 22:26:24 +0000 hourly 1 By: John M. Grohol, Psy.D. http://psychcentral.com/blog/archives/2007/08/10/wyeth-schizophrenia-drug-bifeprunox-suffers-setback/comment-page-1/#comment-276186 John M. Grohol, Psy.D. Tue, 18 Sep 2007 22:09:09 +0000 http://psychcentral.com/blog/archives/2007/08/10/wyeth-schizophrenia-drug-bifeprunox-suffers-setback/#comment-276186 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. 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.

]]> By: Rita Plazo http://psychcentral.com/blog/archives/2007/08/10/wyeth-schizophrenia-drug-bifeprunox-suffers-setback/comment-page-1/#comment-276163 Rita Plazo Tue, 18 Sep 2007 21:16:04 +0000 http://psychcentral.com/blog/archives/2007/08/10/wyeth-schizophrenia-drug-bifeprunox-suffers-setback/#comment-276163 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 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

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