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Bristol-Myers Squibb Abilify long-term use

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approves Bristol-Myers Squibb/Otsuka's Abilify (aripiprazole) Aug. 28 for maintaining stability in patients with schizophrenia. The sNDA was based on a 310-patient placebo-controlled trial in which patients who were stable on other antipsychotics were switched to Abilify and treated for up to 26 weeks. Abilify patients "experienced a significantly longer time to relapse over the subsequent 26 weeks compared to those receiving placebo," labeling states. The relative risk of relapse for Abilify patients was half that of placebo patients, according to the firms. The companies also reported that "there were no medically important differences between Abilify and placebo in several metabolic measures." Overall mean weight change was 1.3 kg for Abilify compared to -0.9 kg for placebo. Bristol/Otsuka submitted an sNDA for treatment of acute mania June 25 (1Pharmaceutical Approvals Monthly Aug. 1, 2003, In Brief)...
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