FDA Accepts Alkermes’ Resubmission Of New Drug Application For ALKS 3831 As Treatment For Schizophrenia & Bipolar Disorder

The U.S. Food and Drug Administration (FDA) has acknowledged receipt of a New Drug Application (NDA) resubmitted by Alkermes plc for ALKS 3831 (olanzapine/samidorphan). The medication is intended to treat adults with schizophrenia and adults with bipolar I disorder. The FDA assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.

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. ALKS 3831 is composed of samidorphan, a novel, new . . .