Alkermes plc announced positive topline results from ENLIGHTEN-Early, a phase 3b study that evaluated the effect of LYBALVI® (olanzapine and samidorphan) compared to olanzapine on body weight in young adult patients (ages 16 to 39; mean age: 26 years) with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness. The study met its pre-specified primary endpoint, as patients treated with LYBALVI experienced statistically significantly less weight gain than patients treated with olanzapine at Week 12.

DUBLIN, Oct. 18, 2021 /PRNewswire/ -- Alkermes plc today announced that LYBALVI® (olanzapine and samidorphan) is now available by prescription in the United States for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes as monotherapy or an adjunct to lithium or valproate. LYBALVI is a once-daily, oral atypical antipsychotic composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity.