The FDA rejected the experimental antipsychotic bifeprunox, developed by Solvay Pharmaceuticals and its partner Wyeth. The companies failed to submit enough data to demonstrate that the schizophrenia remedy was effective, Solvay announced. It's a tough blow for the partnership, which had high hopes that bifeprunox would grow into a blockbuster product, and had planned to launch it in 2008.
In addition to efficacy data, the FDA wants to know more about the drug's metabolism in the human body and about the death of one trial participant, which Solvay termed "a complex case."
- see the release [1]
- read this report [2] for more
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Links:
[1] http://www.fiercebiotech.com/press-releases/press-release-wyeth-and-solvay-announce-receipt-fda-action-letter-bifeprunox
[2] http://money.cnn.com/2007/08/10/news/companies/wyeth/?postversion=2007081009
[3] http://www.fiercebiotech.com/story/spotlight-viropharma-s-hcv-drug-shows-promise/2005-11-10
[4] http://www.fiercebiotech.com/story/spotlight-wyeth-buying-viropharma-shares/2006-08-14
[5] http://www.fiercebiotech.com/story/four-promising-companies-watch/2007-08-08