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Asenapine Effective for Acute Mania in Bipolar I Disorder: Presented at ECNP

By Joanna Lyford

VIENNA, AUSTRIA -- October 18, 2007 -- Asenapine, an investigational drug that targets serotonin, alpha-adrenergic, and dopamine receptors, is effective for the treatment of acute mania in patients with bipolar I disorder, according to results from two phase 3 trials.

According to a poster presented here at the 20th European College of Neuropsychopharmacology (ECNP) Congress, asenapine was superior to placebo and noninferior to olanzapine in the treatment of patients experiencing manic or mixed episodes of bipolar I disorder.

"The results of these clinical trials add to the body of evidence supporting the clinical efficacy and safety of asenapine," said the studies' principal investigator Roger McIntyre, MD, Associate Professor of Psychiatry and Pharmacology, University of Toronto, and Head, Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.

"The complex nature of bipolar disorders suggests that we should have many treatment options available to physicians and patients," Dr. McIntyre said. "As such, a new therapy that provides efficacy while also providing improved tolerability is critical in helping fill this unmet need."

The two pivotal trials -- ARES 7501004 and ARES 7501005 -- had identical designs and were conducted in 10 countries in North America, Europe, and Asia. Each trial enrolled adults with moderate-to-severe mania associated with bipolar I disorder and a Young Mania Rating Scale (YMRS) score of 20 or greater. ARES 7501004 enrolled 488 subjects and ARES 7501005 enrolled 489 subjects.

After a run-in period the participants were randomised to 3 weeks of flexible-dose treatment with asenapine 5 to 10 mg BID, olanzapine 5 to 15 mg QD, or placebo.

In each of the trials, the mean change in YMRS score between baseline and day 21 was significantly greater with asenapine and olanzapine than with placebo. Furthermore the superiority of asenapine and olanzapine over placebo on this measure was evident as early as day 2.

Additionally, both asenapine and olanzapine were associated with significant improvements in mania severity on day 21 as assessed with the Clinical Global Impressions - Bipolar Disorder (CGI-BP) scale. Again, this improvement was apparent by day 2 in both trials.

In ARES 7501005, asenapine was also associated with significantly greater response and remission rates versus placebo at day 21. The same trend was seen in ARES 7501004 but it failed to achieve statistical significance.

A 9-week extension study (ARES 7501006) confirmed that asenapine was noninferior to olanzapine with respect to therapeutic response and remission.

The overall incidences of treatment-related adverse events (AEs) for the two studies were 55.1% and 60.8% in the asenapine groups, respectively; 46.8% and 52.9% in the olanzapine groups, respectively; and 27.6% and 36.2% in the placebo groups, respectively.

The AEs most commonly reported with asenapine were sedation, dizziness, and somnolence; most of these were mild to moderate. "Asenapine was well tolerated, with a low incidence of extrapyramidal side effects and weight gain," the authors commented.

They concluded: "Asenapine is effective for the treatment of acute mania in patients with bipolar I disorder."

The research was supported by Organon International Inc. and Pfizer Inc.


[Presentation title: Treatment of Mania in Bipolar I Disorder: A Placebo- and Olanzapine-Controlled Trial of Asenapine (ARES 7501005). Abstract P.2.e.012]

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