Journal Of Clinical Psychiatry Publishes Data from Alkermes’ Phase 3 ENLIGHTEN-1 Efficacy Study For Individuals With Schizophrenia
Alkermes recently announced the publication of results from the phase 3 ENLIGHTEN-1 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, Journal of Clinical Psychiatry. ENLIGHTEN-1 was a four-week study evaluating the efficacy, safety, and tolerability of ALKS 3831 compared to placebo in 403 individuals experiencing an acute exacerbation of schizophrenia. Positive topline data from the ENLIGHTEN-1 study were first reported in June 2017. A New Drug Application for ALKS 3831 is currently under U.S. Food and Drug Administration review, with a Prescription Drug User Fee Act target action date of November . . .