Bristol Revisiting Abilify Bipolar Mania Indication, With Filing By Year-End
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bristol-Myers Squibb and Otsuka will take their second stab at an Abilify indication for bipolar mania via an sNDA submission before the end of 2003.
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Abilify for bipolar mania
Bristol/Otsuka's June 25 Abilify (aripiprazole) submission for treatment of acute bipolar mania is first sought labeling expansion for the atypical antipsychotic. The indication was included in the initial NDA, but Bristol withdrew it after one of two pivotal trials failed to meet the primary endpoint (1Pharmaceutical Approvals Monthly May 1, 2003, p. 27). The sNDA includes three, three-week placebo-controlled studies and one 12-week study comparing Abilify to haloperidol. Abilify did not reach statistical significance in one of the three-week studies; the sponsors attributed the finding to "a high placebo response rate (approximately 40%)." In the other studies, aripiprazole was superior to placebo and comparable to haloperidol. Among the atypicals, acute bipolar mania indications are held by Lilly's Zyprexa (ziprasidone) and pending for AstraZeneca's Seroquel (quetiapine) and J&J's Risperdal (risperidone)...
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