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Psychotropic Drug Asenapine Receives Simultaneous Initial FDA Approval for Schizophrenia and Bipolar I Disorder KENILWORTH, NJ -- August 14, 2009 -- The US Food and Drug Administration (FDA) has approved asenapine (SAPHRIS) sublingual tablets for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. Asenapine can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously. The FDA approval of asenapine is based on a New Drug Application that included efficacy data from a clinical study program involving more than 3,000 patients in schizophrenia and bipolar mania trials. The asenapine filing was supported by safety data in 4,500 people, with some patients treated for more than 2 years. The approval is based on acute schizophrenia trials in which asenapine 5 mg twice daily demonstrated statistically significant efficacy versus placebo and acute bipolar I disorder studies in which asenapine 10 mg twice daily demonstrated statistically significant reduction of bipolar mania symptoms versus placebo. "Schizophrenia and bipolar I disorder are complex medical conditions that can present clinical challenges for the physician," said Steven G. Potkin, MD, Department of Psychiatry and Human Behavior, University of California at Irvine, Irvine, California. Dr Potkin was the lead author of a pivotal schizophrenia study as part of the asenapine clinical development program. "Having a new FDA-approved treatment such as SAPHRIS is important in these serious conditions because physicians need options to help manage their patients' symptoms," said Roger S. McIntyre, MD, Psychiatry and Pharmacology, University of Toronto, Toronto, Ontario, lead author of the pivotal bipolar mania studies as part of the asenapine clinical development program. Asenapine is expected to be available in the United States during the fourth quarter of 2009. SOURCE: Schering-Plough E-mail this page to a friend or colleague! To print, use this version