Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annu...(welcomeadditions to the treatment option...),Health

Schering-Plough acquired asenapine in November 2007 through its combination with Organon BioSciences, which developed the investigational antipsychotic agent. The Food and Drug Administration is reviewing a new drug application (NDA) for asenapine in the treatment for schizophrenia and acute manic or mixed episodes associated with bipolar I disorder. The asenapine Olympia clinical trial program thus far has involved over 3,000 patients and has included bipolar mania and acute schizophrenia trials.

"Based on results from the Olympia trial program, we believe asenapine has the potential to address a clinically important unmet need for patients with schizophrenia and bipolar disorder," said Robert J. Spiegel, M.D., Chief Medical Officer and Senior Vice President, Schering-Plough Research Institute.

Olympia Data: Bipolar I Disorder

The bipolar I disorder program includes two placebo- and active-controlled, three-week trials followed by an extension study totaling one year of treatment involving nearly 1,000 patients with bipolar I disorder. Treatment response was measured using the Young Mania Rating Scale (YMRS) score, an 11-item scale used to evaluate manic symptoms.

In the trials, both asenapine and the active-control drug olanzapine* produced greater mean reductions in YMRS total scores versus placebo after three weeks of treatment. Asenapine produced 13- and 14-point reductions in the YMRS total score from baseline to day 21 (P<0.05 versus placebo; olanzapine was also demonstrated to be statistically superior to placebo; there was no direct comparison between asenapine and olanzapine). In a 9-week extension of the 3-week trials, asenapine was found to be noninferior to olanzapine on the primary efficacy measure, change in YMRS.

The overall incidence of treatment-related adverse events (AEs) in the trials was 60.8 percent in the asena
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