Two advisory committees, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the US Food and Drug Administration (FDA) have voted in favor of ALKS 3831, a combination of olanzapine and samidorphan. The committees jointly voted that samidorphan meaningfully mitigates weight gain associated with olanzapine (16 yes, 1 no) and that ALKS 3831s safety profile 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). The combination of olanzapine, a dopamine D2 receptor antagonist, and samidorphan, an opioid receptor antagonist, is being developed for the treatment of schizophrenia and bipolar I disorder. Despite its efficacy, olanzapine is associated with significant weight gain and adverse metabolic effects that limit its clinical utility as a monotherapy. The joint advisory committee's recommendations are not binding, but 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 Nov. 15, 2020.
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