MARIETTA, Ga., Aug. 10 /PRNewswire/ -- Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE - News), announced today the receipt of an action letter from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for bifeprunox, an atypical antipsychotic that was reviewed for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients. The Agency stated that the drug was not approvable at this time.
The FDA stated in the letter that bifeprunox demonstrated effectiveness in the long-term maintenance study and indicated that a second positive maintenance study could be sufficient to support a maintenance claim for bifeprunox. The Companies believe that bifeprunox offers distinct benefits for the long-term maintenance of patients with schizophrenia. The Companies will meet with the FDA to discuss the study design and to assess how this additional study combined with ongoing and planned studies can support a maintenance indication.
Although the FDA acknowledged that bifeprunox separated from placebo in two short-term studies in the acute setting, the Agency concluded that the efficacy data, when compared to reference drugs, were not sufficient for approval.
The Agency also requested further information regarding human metabolism of bifeprunox, and information regarding a complex case of a patient who died while participating in one of the trials.
"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," says Laurence Downey, M.D., President and CEO of Solvay Pharmaceuticals, Inc. "We will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible."
"The development of bifeprunox offers the possibility of a new treatment approach for patients where maintaining stability is challenged by the metabolic consequences frequently encountered with long-term therapy. We continue to support the development of the compound and the approach," adds Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals.
Bifeprunox, a partial dopamine agonist designed to normalize levels of chemical activity in the brain, has been studied in approximately 2,650 patients with schizophrenia at more than 200 Phase 2 and 3 clinical trial sites in the United States and throughout the world.
About Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc., of Marietta, Georgia, is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology, and men's and women's health. Its 2006 sales were EUR 2.6 billion and it employs approximately 10,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
SOLVAY is an international chemical and pharmaceutical Group with headquarters in Brussels. It employs some 30,000 people in 50 countries. In 2006 its consolidated sales amounted to EUR 9.4 billion generated by its three activity sectors: Chemicals, Plastics and Pharmaceuticals. SOLVAY (Euronext: SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR) is listed on the Euronext stock exchange in Brussels.
Details are available at www.solvay.com.
Source: Solvay Pharmaceuticals, Inc.