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Organon's Asenapine Effective in a Phase III Study for the,Treatment of Bipolar I Disorder; Results Unveiled at 2007 APA,Meeting

SAN DIEGO, May 21, 2007 /PRNewswire/ -- Asenapine -- an investigational drug being developed by Organon, the human healthcare business unit of Akzo Nobel, for bipolar I disorder and schizophrenia -- was demonstrated to be more effective than placebo in treating acute manic and mixed episodes associated with bipolar I disorder, according to new Phase III results, from a study presented at the American Psychiatric Association's 2007 Annual Meeting.

In the three-week study, patients treated with either asenapine or olanzapine experienced significant improvements in acute mania symptoms, versus patients given placebo. Both asenapine and olanzapine demonstrated superiority versus placebo by the second day of treatment and maintained this benefit throughout the trial.

"The consequences of untreated mania in patients with bipolar disorder can be devastating to patients and their families. We need more effective and more tolerable treatments for these patients," said Robert Hirschfeld, M.D., Professor and Chair of the Department of Psychiatry and Behavioral Sciences at The University of Texas Medical Branch, Galveston. "The results of this trial suggest that asenapine is an attractive option for the acute treatment of mania because of its rapid onset of action and modest side effect profile."

Phase III Study Overview

The Phase III, double-blind, international trial conducted at 55 centers including 29 sites in the United States enrolled 488 patients with a manic (69%) or a mixed episode (31%) of bipolar I disorder and a baseline Young Mania Rating Scale (YMRS) score greater than or equal to 20 at entry. The YMRS is an 11-item scale used to evaluate manic symptoms; a score of at least 20 represents moderate-to-severe mania. Patients were randomly treated with asenapine (5-10 mg twice daily; average daily dose, 18.2 mg), olanzapine (5-20 mg once daily; average daily dose, 15.8 mg), or placebo
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