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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

eduction between the active treatments and placebo was seen as early as day two (1).

The overall incidences of treatment-related adverse events (AEs) for the two studies were 55.1% and 60.8% in the asenapine groups, 46.8% and 52.9% in the olanzapine groups, and 27.6% and 36.2% in the placebo groups. Most adverse events were mild to moderate. The most commonly reported AEs (reported by >5% of the patients and at twice the incidence of placebo in both studies) with asenapine included sedation, dizziness and somnolence. Olanzapine was most commonly associated with sedation, dizziness, somnolence and weight increase. The incidence of extrapyramidal symptoms reported as an adverse event was 10.3% and 7.2% in the asenapine group, 6.8% and 7.9% in the olanzapine group, and 3.1% and 2.9% in the placebo group.

Asenapine-treated patients had approximately a two-fold lower incidence of clinically significant weight gain (greater than or equal to 7%) versus olanzapine-treated patients in Ares 7501004 (7% vs. 19%, respectively) and in Ares 7501005 (6% vs.13%, respectively).

The study abstract, "Treatment of mania in bipolar I disorder: a placebo and olanzapine-controlled trial of asenapine," (P.2.e.012) was presented at ECNP on Tuesday, 16 October by Professor McIntyre.

Study overview: schizophrenia (presented on Sunday, 14 October at 12:00 p.m. CEST)

This 16-day, multicenter study examined the effects of asenapine on the QT interval -- a measure of the heart's electrical conductance. A QTc >500 milliseconds (msec) and an increase from baseline of >60 msec are risk factors for a potentially life-threatening form of ventricular tachycardia called torsades de pointes.

In the study, 151 patients with schizophrenia or schizoaffective disorder were randomized to asenapine (up to 20 mg twice daily), quetiapine 375 mg twice daily, or placebo. Investigators measured QTc using electrocardiograms (ECGs), which were administered several times throughout
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SOURCE Organon
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