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Organon's Asenapine Further Demonstrates Efficacy in Reducing Mania Symptoms for the Treatment of Bipolar I Disorder
Date:10/17/2007

New Data From a Separate Study Also Show Minimal Effect on Heart Rhythm

Changes in Schizophrenia Patients

VIENNA, Austria, Oct. 17 /PRNewswire/ -- New data show that asenapine -- a psychopharmacologic agent being developed by Organon -- is effective in treating acute manic episodes associated with bipolar I disorder. These results, from two Phase III clinical studies, were presented this week at the 20th European College of Neuropsychopharmacology (ECNP) Congress.

"The results of these clinical trials add to the body of evidence supporting the clinical efficacy and safety of asenapine," said Roger S. McIntyre, M.D., Associate Professor of Psychiatry and Pharmacology at the University of Toronto and Head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada. "The complex nature of bipolar disorders suggests that we should have many treatment options available to physicians and patients. As such, a new therapy that provides efficacy while also providing improved tolerability is critical in helping fill this unmet need."

In a separate safety study, also presented at the ECNP, asenapine demonstrated minimal effect on the QT interval (QTc) -- a measure of the heart's electrical conductance -- in patients with schizophrenia.

Study overview: bipolar I disorder (presented on Tuesday, 16 October at 12:00 p.m. CEST)

In the two Phase III, randomized, double-blind trials (Ares 7501004 and Ares 7501005), 960 adult patients with moderate-to-severe mania associated with bipolar I disorder received either asenapine (5-10 mg twice daily), olanzapine (5-20 mg once daily), or placebo for three weeks.

At day 21 in both studies, both asenapine and olanzapine produced significant mean improvements in mania symptoms versus placebo as measured by changes in YMRS (Young Mania Rating Scale) score. The YMRS is an 11-item scale used to evaluate manic symptoms. A difference in YMRS score r
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SOURCE Organon
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