Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annu...(pine group 52.9 percent in theolanzapine...),Health

Date:5/8/2008

pine group, 52.9 percent in the olanzapine group, and 36.2 percent in the placebo group. The most commonly reported adverse events (greater than or equal to 5 percent and twice the rate of placebo) with asenapine included sedation, dizziness, somnolence, oral hypoesthesia (numbness) and weight increase.

Presentation of the overview of the Olympia Program in bipolar I disorder (oral abstract #44) was on Tuesday, May 6, at 12:00 pm in Room 151A.

Olympia Data: Schizophrenia

The schizophrenia program includes four placebo- and active-controlled, six-week trials involving more than 1,300 patients with schizophrenia. In two of the trials involving almost 700 patients, asenapine produced 19- to 20-point reductions in Positive and Negative Syndrome Scale (PANSS) total score and was significantly superior to placebo. PANSS total score is a measure of positive symptoms (e.g., hallucinations and delusions), negative symptoms (such as lack of emotional expression), and general psychopathology symptoms (such as anxiety and depression).

The third study in approximately 260 patients was considered a failed trial as neither asenapine nor the active control olanzapine differentiated from placebo. A fourth trial of approximately 400 patients with acute schizophrenia was considered a negative trial, as the active-control (olanzapine) differentiated from placebo whereas asenapine did not.

The most commonly reported AEs (greater than or equal to 5 percent and twice the rate of placebo) among patients taking asenapine in the short-term schizophrenia trials were somnolence, akathisia (restlessness) and oral hypoesthesia (numbness).

"Schizophrenia is a lifelong illness that requires ongoing treatment to effectively manage the spectrum of symptoms that patients suffer from. As such, new treatments need to demonstrate an acceptable long-term safety profile," said Steven Potkin, M.D., Professor, Department of Psychiatry and Human Behavior, University
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