FDAnews
www.fdanews.com/articles/63293-solvay-wyeth-submit-nda-for-schizophrenia-drug

SOLVAY, WYETH SUBMIT NDA FOR SCHIZOPHRENIA DRUG

October 13, 2006

Solvay Pharmaceuticals and Wyeth announced hat a new drug application (NDA) has been submitted to the FDA for bifeprunox, an investigational atypical antipsychotic for the treatment of schizophrenia.

The NDA submission is based on safety and efficacy studies that evaluated bifeprunox for the treatment of schizophrenia in approximately 2,550 patients. Patients were evaluated with acute exacerbations for six weeks, and stable patients were evaluated for six months.

In March 2004, Solvay 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 co-commercialize bifeprunox and 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 with psychotic features and other indications.