Alkermes’ Lybalvi featured in study published in Journal of Clinical Psychiatry

Alkermes announced the publication of results from its phase 3 ENLIGHTEN-Early study of Lybalvi in the peer-reviewed publication, the Journal of Clinical Psychiatry. ENLIGHTEN-Early evaluated the effect of Lybalvi compared to olanzapine on body weight in young adult patients with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness. Alkermes first reported the positive topline data from the ENLIGHTEN-Early study-including details on the primary and secondary endpoints-in February 2022. Lybalvi is approved in the U.S. for the treatment of schizophrenia in adults, and for the treatment of bipolar I disorder in adults, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or as adjunct to lithium or valproate. The ENLIGHTEN-Early study met its prespecified primary endpoint, demonstrating that patients treated with Lybalvi experienced statistically significantly less weight gain than patients treated with olanzapine at Week 12. The safety profile of Lybalvi was consistent with previous studies.