Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annu... (of California Irvine. We are encouraged...)

Overview of Asenapine Data from Olympia Trial Program Presented at American Psychiatric Association Annual Meeting

Date:5/8/2008

of California, Irvine. "We are encouraged that in the long-term trial, asenapine had a lower incidence of clinically significant weight gain (15%) vs olanzapine (36%)."

Presentation of the overview of the Olympia Program in schizophrenia (oral abstract #80) is on Thursday, May 8, at 11:00 am in Room 101.

Long-term Safety and Efficacy Data

In a year long, double-blind, randomized study of 1200 patients with schizophrenia or schizoaffective disorder treated with asenapine or olanzapine (3:1 randomization), the safety evaluation showed that the overall rates of AEs were similar for the asenapine 5-10 mg BID arm and olanzapine 10-20 mg QD arm (drug-related AEs, 60 percent and 61 percent respectively; withdrawal due to serious adverse events, 6.3 percent and 6.8 percent, respectively). On efficacy measures, improvements in PANSS total score were greatest for both asenapine and olanzapine within the first six to eight weeks of treatment and were maintained throughout the 52-week study period. In an exploratory secondary analysis, the between-group difference at 52 weeks favored olanzapine. Most commonly reported AEs (greater than or equal to 10 percent) in both treatment groups were insomnia, worsening psychotic symptoms, weight gain and depression.

Additional Asenapine Data Presentations

Additional asenapine data were presented in poster sessions during the meeting.

About Bipolar Disorder

Bipolar disorder, commonly referred to as manic-depressive disorder, is a chronic, episodic illness characterized by mania (episodes of elevated moods, extreme irritability, and increased energy), depression (overwhelming feelings of sadness, suicidal thoughts), or a combination of both. It affects approximately 1 to 5 percent of adults, including more than 10 million adults in the U.S. and more than four million people in Europe.(2,3,4) The condition can start early in childhood or later in life, with the average age of onset between 15
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