The FDA has approved Saphris (asenapine sublingual tablets, from Schering-Plough), a psychotropic agent, for the acute treatment of schizophrenia in adults and the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. Saphris can be used as first-line therapy. This approval was based on results from acute schizophrenia trials in which Saphris demonstrated statistically significant efficacy versus placebo and acute bipolar I disorder studies in which Saphris demonstrated statistically significant reduction of bipolar mania symptoms versus placebo.
Saphris is expected to be made available during the fourth quarter of 2009 in 5mg and 10mg dosage strengths.
For more information call (800) 526-4099 or visit www.saphris.com.