Virtual FDA advisory committee meeting to review NDA for ALKS 3831 for treatment of schizophrenia and bipolar I disorder tentatively scheduled for 9 October 2020.- Alkermes plc.

Alkermes plc announced that a joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) has been tentatively scheduled for 9 October, 2020. ALKS 3831 is 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 Prescription Drug User Fee Act (PDUFA) action date for the ALKS 3831 NDA is 15 November 2020. It is expected that the advisory committee panel will review the efficacy, safety, and benefit-risk profile of ALKS 3831 for the proposed indications of schizophrenia and bipolar I disorder. As announced previously, the company expects the advisory panel to focus on the clinical meaningfulness of ALKS 3831's attenuation of olanzapine-associated weight gain, including the magnitude of weight effect and the impact of ALKS 3831 on laboratory-based metabolic parameters. Since that time, the company has learned that the panel will also discuss certain potential clinical risks related to the interaction of ALKS 3831, which includes samidorphan, an opioid receptor antagonist, and opioids in the intended patient populations.