DUBLIN, Aug. 21, 2020 /PRNewswire/ --Alkermes plc(NASDAQ:ALKS) today announced that a joint meeting of the U.S. Food and Drug Administration's (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 Oct. 9, 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 Nov. 15, 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 potentialclinical risks related tothe interaction of ALKS 3831, which includes samidorphan, an opioid receptor antagonist, and opioids in the intended patient populations.
"We look forward to engaging with members of the joint advisory committee panel in a robust discussion of the clinical evidence for ALKS 3831," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "For adults living with schizophrenia or bipolar I disorder, populations already prone to shortened life expectancy and cardiovascular comorbidities, the significant weight gain often associated with olanzapine can represent a major clinical liability. Patients and healthcare providers may benefit from additional treatment options that help manage disease symptoms while mitigating weight gain. We are committed to bringing this potential new medicine to adults living with schizophrenia or bipolar I disorder."
The NDA submission and clinical development program for ALKS 3831 are supported by data from 27 clinical studies, including 18studies evaluating ALKS 3831 and ninestudies evaluating samidorphan alone.Throughout the clinical development program, ALKS 3831 showed evidence of antipsychotic efficacy, safety and tolerability, including attenuation of olanzapine-associated weight gain.