Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth, announced that a New Drug Application (NDA) was submitted to the US Food and Drug Administration (FDA) for bifeprunox, an investigational atypical antipsychotic for the treatment of schizophrenia.

"The NDA submission of bifeprunox is an important milestone in our commitment to develop and commercialize compounds that potentially address the long-term treatment outcomes of patients with mental illnesses," says Laurence Downey, M.D., president and CEO of Solvay Pharmaceuticals, Inc. "In addition to our research in schizophrenia, we're also exploring other treatments for other psychiatric disorders."

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.

"One recent US government-sponsored study, CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness), showed a significant need for new treatment options, especially over the long-term," says Joseph Camardo, M.D., senior vice president of Global Medical Affairs, Wyeth Pharmaceuticals. "We are pleased that our collaboration with Solvay Pharmaceuticals has resulted in an application with proposed indications for both initial therapy and maintenance, which is an important feature for an atypical antipsychotic."

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 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.