The FDA has issued a non-approvable letter to Solvay and development partner Wyeth for bifeprunox, an antipsychotic for the treatment of schizophrenia. In order to gain approval, Wyeth and Solvay must conduct a second study of bifeprunox to prove long-term positive maintenance. The FDA also requested more data regarding human metabolism of bifeprunox. This is a second dose of bad news for Wyeth, which recently received an approvable letter for Pristiq.
"We believe that bifeprunox is a promising drug for the treatment of schizophrenia and that there is a need for new treatment options to help people with schizophrenia manage their disease," said Laurence Downey, M.D., President and CEO of Solvay Pharmaceuticals in a release. "We will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible."
- see the release
- read the Wall Street Journal article