( for three weeks. Dosing was flexible. T...)Organon's Asenapine Effective in a Phase III Study for the,Treatment of Bipolar I Disorder; Results Unveiled at 2007 APA,Meeting,Health

for three weeks. Dosing was flexible. The primary efficacy endpoint was a reduction in YMRS total score at day 21. Safety measures included adverse events, weight gain and scores on measures of extrapyramidal symptoms (neurological symptoms such as involuntary movement, rigidity, and tremors often associated with antipsychotic medications).(i)

At day 2, both asenapine and olanzapine provided greater mean reductions in YMRS scores versus placebo (-3.0 and -3.4, respectively, vs. -1.5; p<0.008 for asenapine, p<0.001 for olanzapine). At the end of the trial (day 21), both active treatments continued to produce significant mean improvements in mania symptoms versus placebo (-10.8 and -12.6, respectively, vs. -5.5; both p<0.0001).(i)

The overall incidence of treatment-related adverse events was 60.8% in the asenapine group, 52.9% in the olanzapine group, and 36.2% in the placebo group. Most adverse events were mild to moderate. The most commonly reported AEs (>6%) with asenapine included sedation, dizziness, headache, somnolence, and fatigue. Olanzapine was most commonly associated with sedation, dry mouth, dizziness, headache, somnolence, and weight gain. The incidence of extrapyramidal symptoms reported as an adverse event was 7.2% in the asenapine group, 7.9% in the olanzapine group, and 2.9% in the placebo group.(i)

Asenapine was found to be effective and safe in the treatment of acute mania associated with bipolar I disorder in this study.

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. Approximately 5.7 million people in the United States ages 18 and older (2.6 percent of the population) have bipolar disorder. The estimated annual costs in the United States related to bip
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