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news.Solvay and Wyeth Pharmaceuticals have jointly submitted a new drug application to the FDA for bifeprunox, an antipsychotic drug used to treat patients with schizophrenia.
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The submission is based on safety and efficacy studies that evaluated bifeprunox for the treatment of schizophrenia. Patients were evaluated with acute exacerbations for six weeks, and stable patients were evaluated for six months
“One recent US government-sponsored study, CATIE, showed a significant need for new treatment options, especially over the long-term,” said Joseph Camardo, senior vice president of Global Medical Affairs, Wyeth Pharmaceuticals
In March 2004, Solvay Pharmaceuticals and Wyeth entered into a collaboration agreement exclusively dedicated to neuroscience research and development. Under the terms of the agreement, the partners will co-develop and commercialize bifeprunox.
The partnership includes the development of two other compounds currently known as SLV-313 and SLV-314, which are in earlier stages of development as treatments for schizophrenia, bipolar disorder, major depressive disorder and other indications.