First psychotropic drug to receive initial approval for both indications simultaneously
KENILWORTH, N.J., Aug. 14 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved SAPHRIS((R)) (asenapine) 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. SAPHRIS can be used as a first-line treatment and is the first psychotropic drug to receive initial approval for both of these indications simultaneously.
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"We are very pleased with the U.S. approval of SAPHRIS, which represents an important new choice for acute treatment of schizophrenia and acute manic or mixed episodes of bipolar I disorder in patients starting treatment and those who have discontinued previous treatment," said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. "SAPHRIS is an important addition to Schering-Plough's product portfolio, and represents the first U.S. approval resulting from the Organon/Schering-Plough combination."
SAPHRIS is expected to be available in the U.S. during the fourth quarter of 2009.
Schizophrenia affects about 24 million people worldwide, including two million Americans, and bipolar I disorder affects about 1 percent of adults, including 10 million Americans.
"Schizophrenia and bipolar I disorder are complex medical conditions that can present clinical challenges for the physician," said Steven G. Potkin, M.D., professor, department of psychiatry and human behavior, University of California, Irvine, and lead author of a pivotal schizophrenia study as part of the SAPHRIS 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, M.D., associate professor of psychiatry and pharmacology, University of Toronto, Canada, and lead author of the pivotal bipolar mania studies as part of the SAPHRIS clinical development program.
The FDA approval of SAPHRIS is based on a New Drug Application (NDA) that included efficacy data from a clinical study program involving more than 3,000 patients in schizophrenia and bipolar mania trials. The SAPHRIS filing was supported by safety data in 4,500 people, with some patients treated for more than two years. The approval is based on acute schizophrenia trials in which SAPHRIS (5 mg twice daily) demonstrated statistically significant efficacy versus placebo and acute bipolar I disorder studies in which SAPHRIS (10 mg twice daily) demonstrated statistically significant reduction of bipolar mania symptoms versus placebo.
About SAPHRIS (asenapine)
SAPHRIS is a psychotropic agent indicated 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. Schering-Plough has reported additional top-line results for SAPHRIS in long-term clinical studies. Additional clinical studies with SAPHRIS are ongoing.
In Europe, a Marketing Authorization Application (MAA) for asenapine, under the brand name SYCREST((R)), is currently under review by the European Medicines Agency (EMEA) for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.
Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.
Important Safety Information about SAPHRIS
Increased Mortality in Elderly Patients with Dementia-Related Psychosis:
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5 percent compared to a rate of 2.6 percent in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.
