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Abilify long-term sNDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb and Otsuka submit Abilify (aripiprazole) for long-term treatment of schizophrenia, the firms announce Feb. 25. The sNDA is based on a 26-week, 310-patient trial comparing Abilify 15 mg to placebo; the study found the atypical antipsychotic's relative risk of relapse to be half that of placebo (0.503, p<0.001). Discontinuations due to adverse events were 10% for Abilify vs. 8% for placebo, with insomnia, tremor, akathisia, vomiting and nausea as the most frequent AEs. Labeling for Lilly's Zyprexa (olanzapine), Pfizer's Geodon (ziprasidone) and Janssen's Risperdal (risperidone) all contain statements of proven efficacy for periods ranging from eight months to two years, with recommendations for re-evaluation of long-term risks/benefit
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