FDA Advisory Committee votes in support of ALKS 3831 for the treatment of schizophrenia and bipolar I disorder.- Alkermes

Alkermes plc announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the FDA. The committees met to discuss ALKS 3831 (olanzapine/samidorphan), an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. The committees jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain (16 yes, 1 no) and that the safety profile of ALKS 3831 has been adequately characterized (13 yes, 3 no, 1 abstention. In addition, the committees jointly voted that labeling is sufficient to mitigate the risks related to the opioid antagonist action of samidorphan (11 yes, 6 no). Alkermes' proposed labeling contraindicates the use of ALKS 3831 in patients who are opioid-dependent or chronically using opioids, and the company has proposed a comprehensive education plan, which includes dissemination of information to potential prescribers and pharmacists. The joint advisory committee's recommendations, while not binding, will be considered by the FDA in its review of the ALKS 3831 New Drug Application (NDA). The Prescription Drug User Fee Act (PDUFA) target action date for the ALKS 3831 NDA is 15 November, 2020.