Phase III ENLIGHTEN-2 trial of ALKS 3831 in schizophrenia published in American Journal of Psychiatry.- Alkermes

Alkermes announced the publication of results from the phase III ENLIGHTEN-2 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, American Journal of Psychiatry. ENLIGHTEN-2 was a six-month study evaluating the weight gain profile of ALKS 3831 compared to olanzapine in 561 patients with stable schizophrenia. Positive topline data from the ENLIGHTEN-2 study were first reported in November 2018. ENLIGHTEN-2 is the second of two key studies included in the ALKS 3831 ENLIGHTEN clinical development program. ENLIGHTEN-1, the first phase III study, evaluated the efficacy, safety and tolerability of ALKS 3831 compared to placebo in patients experiencing an acute exacerbation of schizophrenia. Positive topline data from the ENLIGHTEN-1 study were first reported in June 2017 and full results were later published in the peer-reviewed publication, Journal of Clinical Psychiatry. A New Drug Application (NDA) for ALKS 3831 for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder is currently under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020.See: Potkin et al. "Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia: Outcomes From the Randomized, Phase 3 ENLIGHTEN-1 Study." J Clin Psych, 2020;81(2):19m12769. https://doi.org/10.4088/JCP.19m12769