June 12, 2006

Solvey & Wyeth moving ahead with testing of Bifeprunox

It was announced this week that Solvay is recruiting patients for a phase II trial in the USA, which started in January 2006. This randomized, double-blind, placebo-controlled study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects.

The study is to be two months long with an optional open-label 26-week extension study. Wyeth is working towards filing an FDA approval and commercial launch of the drug for the treatment of schizophrenia by mid 2007, and the company is conducting a phase III trial in the treatment of schizophrenia in Europe. Mechanism of action of bifeprunox couples a highly potent partial agonism of the dopamine D2 receptors to an additional 5HT1A receptor partial agonist effect. Wyeth will be marketing the drug in the USA, Solvay will be marketing the drug in Europe and the rest of the world.

Of course - given the long history of medications with significant side effects - a healthy skepticism should be used when evaluating any new drug claims.

More information:

Bifeprunox clinical trial information

Bifeprunox - at Solvay Pharmaceuticals



If its mid 2006 now, I don't know how they expect it to be launched by mid 2007. The USA application takes over a year, if approved.

Posted by: Robert at June 12, 2006 02:42 PM

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