The US Food and Drug Administration (FDA) has approved Schering-Plough‘s Saphris, for the treatment of schizophrenia and for episodes associated with severe bipolar disorder.
The drug, which will be used as a first-line treatment, is the first psychotropic drug to be approved for both disorders simultaneously.
FDA approval of Saphris was based on data from a clinical study programme involving more than 3,000 patients in schizophrenia and bipolar mania trials.
During the trials Saphris demonstrated statistically significant efficacy in acute schizophrenia trials and in the reduction of bipolar mania symptoms versus placebo.
Schering-Plough Research Institute executive vice-president and president Thomas P Koestler said that Saphris represents an important new choice for treatment.
“Saphris is an important addition to Schering-Plough’s product portfolio, and represents the first US approval resulting from the Organon/Schering-Plough combination,” Koestler said.
Saphris is expected to be available during the fourth quarter of 2009 in the US.