Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co. Ltd. announced that a Supplemental New Drug Application (sNDA) for Abilify (aripiprazole) for the treatment of acute mania in patients with bipolar disorder has been submitted to the U.S. Food and Drug Administration (FDA). FDA approved ABILIFY for the treatment of schizophrenia in November 2002.

The sNDA filing is based on efficacy and safety data from three 3-week placebo-controlled studies and a 12-week active-controlled study in the treatment of acute mania. The four trials examined the efficacy and safety of Abilify at doses of 15-30 mg daily using the Young Mania Rating Scale (Y-MRS) as the primary assessment tool.

Data from two of the three placebo-controlled studies showed Abilify to be superior to placebo in symptom improvement. In these two pivotal trials, improvement with Abilify as measured by the Y-MRS was statistically superior to placebo by Day 4. In the third trial, Abilify demonstrated symptom improvement comparable to that of the other studies; however, due to a high placebo response rate (approximately 40%), Abilify did not show statistical separation from placebo.

In the active-controlled study, Abilify demonstrated comparable symptom improvement (as measured by improvement in Y-MRS score) and a significantly higher response rate compared to that of haloperidol (50% vs. 28%; p<0.001). Response was defined as a greater than or equal to 50% decrease in scores on the Y-MRS while remaining on therapy.

"The data in this sNDA submission examined Abilify in the treatment of acute mania," said Joseph R. Calabrese, Professor of Psychiatry, Case Western Reserve University School of Medicine, and Director, Mood Disorders Program, University Hospitals of Cleveland. "ABILIFY is an important therapeutic option for the treatment of schizophrenia, given its proven efficacy, safety and tolerability profile. Evaluating the use of Abilify in patients with acute mania is also critical, because additional treatment options for this illness are needed."