Alkermes plc announced that LYBALVI® (olanzapine and samidorphan) is now available by prescription in the United States (U.S.) 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. In the ENLIGHTEN clinical development program, LYBALVI demonstrated antipsychotic efficacy, safety and tolerability. Results from the ENLIGHTEN program's pivotal ENLIGHTEN-1 study in schizophrenia, which demonstrated antipsychotic efficacy compared to placebo, and ENLIGHTEN-2 study in schizophrenia, which demonstrated LYBALVI's effect on weight gain compared to olanzapine, as well as their respective 52-week extension studies, have been published in peer-reviewed journals. The U.S. Food and Drug Administration (FDA) approved LYBALVI under the 505(b)(2) regulatory pathway based on data from 27 clinical studies, including 18 studies evaluating LYBALVI and nine studies evaluating samidorphan alone, and the FDA's findings of safety and effectiveness of olanzapine in the treatment of bipolar I disorder and schizophrenia.