Alkermes Reports Positive Topline Results From Phase 3 Study Of ALKS 3831

(RTTNews) - Alkermes plc (ALKS) announced positive topline results from ENLIGHTEN-2, a pivotal phase 3 study of ALKS 3831 (olanzapine/samidorphan), an investigational, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia. In the study, ALKS 3831 met the pre-specified co-primary endpoints, demonstrating both a lower mean percent weight gain from baseline at six months compared to the olanzapine group and a lower proportion of patients who gained 10% or more of their baseline body weight at six months compared to the olanzapine group. The study also met its pre-specified key secondary endpoint, with the ALKS 3831 treatment group demonstrating a lower proportion of patients who gained 7% or more of their baseline body weight at six months compared to the olanzapine group.

Alkermes plans to submit a New Drug Application to the U.S. Food and Drug Administration in mid-2019.