Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that a New Drug Application (NDA) was submitted to the U.S. 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 U.S. 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 codevelop and cocommercialize 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.
Schizophrenia is a chronic form of psychosis that affects approximately three million North Americans. It is characterized by positive and negative symptoms such as hallucinations, delusions, poverty of speech, disorganized thought and emotional blunting. Severity of the symptoms and the long-term pattern of schizophrenia often cause a high degree of disability for patients and place a burden on families, caregivers and communities. Medications for schizophrenia can help reduce and control the distressing symptoms of the illness.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
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