American Journal of Psychiatry Publishes Data From Alkermes' Phase 3 ENLIGHTEN-2 Weight Study of ALKS 3831 in Patients With Schizophrenia

DUBLIN, Aug. 17, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the publication of results from the phase 3 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.

The full manuscript, titled "Effects of Olanzapine Combined With Samidorphan on Weight Gain in Schizophrenia: A 24-Week Phase 3 Study," is now accessible online. External publication authors include: René Kahn, M.D., Ph.D., Icahn School of Medicine at Mount Sinai (corresponding author); Christoph Correll, M.D., Barbara and Donald Zucker School of Medicine at Hofstra/Northwell; and John Newcomer, M.D., Washington University School of Medicine in St. Louis.

"The publication of the ENLIGHTEN-2 data in a peer-reviewed journal represents an important milestone for the ALKS 3831 development program and demonstrates Alkermes' dedication to expanding the body of research on schizophrenia treatment," said Craig Hopkinson, M.D., Executive Vice President, Research & Development and Chief Medical Officer at Alkermes. "Alkermes remains committed to developing and bringing to market potential new medicines that may help people living with serious mental illness and their families."

ENLIGHTEN-2 is the second of two key studies included in the ALKS 3831 ENLIGHTEN clinical development program. ENLIGHTEN-1, the first phase 3 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.¹

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 U.S. Food and Drug Administration (FDA) review, with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020.

About ALKS 3831
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 molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.