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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)...

Abilify Manufacturing Site Withdrawn In Response To "Approvable" Letter

Bristol-Myers Squibb withdrew its proposed finished dosage manufacturing facility for Abilify in Mayaguez, Puerto Rico, six weeks before approval of the antipsychotic.

Bristol/Otsuka To Submit Abilify Long-Term Efficacy sNDA As Phase IV

Otsuka/Bristol-Myers Squibb are required to submit an NDA supplement before the end of 2002 on long-term efficacy of its schizophrenia drug Abilify

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