Schering-Plough Corporation announced that the US Food and Drug Administration (FDA) has approved Saphris (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.
"We are very pleased with the US 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, executive vice president and president, Schering-Plough Research Institute. "Saphris is an important addition to Schering-Plough's product portfolio, and represents the first US approval resulting from the Organon/Schering-Plough combination."
Saphris is expected to be available in the US during the fourth quarter of 2009.
Schizophrenia affects about 24 million people worldwide, including two million Americans, and bipolar I disorder affects about 1 per cent 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, professor, department of psychiatry and human behaviour, University of California, Irvine, and lead author of a pivotal schizophrenia study as part of the Saphris clinical development programme.
"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, 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 programme.
The FDA approval of Saphris is based on a New Drug Application (NDA) that included efficacy data from a clinical study programme 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.
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.