Press Release

Disclosures: Hopkinson reports being an employee of and owning stock/options in Alkermes Inc.
June 08, 2021
1 min read

FDA approves olanzapine/samidorphan treatment for schizophrenia, bipolar 1 disorder


Press Release

Disclosures: Hopkinson reports being an employee of and owning stock/options in Alkermes Inc.
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The FDA has approved an olanzapine/samidorphan combination treatment for schizophrenia and bipolar 1 disorder in adults.

“Olanzapine was once the leading oral atypical antipsychotic treatment, but its utilization has declined due primarily to its common weight and metabolic side effects,” Craig Hopkinson, MD, chief medical officer and executive vice president of Clinical Development and Medical Affairs at Alkermes, told Healio Psychiatry. “Further, our market research shows that antipsychotic efficacy is a critical attribute and considered first by health care providers when selecting a treatment. Lybalvi (olanzapine and samidorphan; Alkermes) was approved for the treatment of schizophrenia in adults and bipolar I disorder in adults as acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate, and as maintenance monotherapy treatment.”

infographic with Hopkinson quote

According to Hopkinson, the treatment’s label reflects information from ENLIGHTEN-1, a phase 3 efficacy study among patients with schizophrenia, and from ENLIGHTEN-2, a phase 3 weight study among patients with schizophrenia. Specifically, Lybalvi showed antipsychotic efficacy, safety and tolerability, including statistically significantly less weight gain compared with olanzapine, among patients with schizophrenia in the ENLIGHTEN-2 study. For its approval decision, the FDA reviewed data from 27 clinical studies, including 18 that evaluated Lybalvi and nine that evaluated samidorphan alone. It also considered its own findings regarding safety and effectiveness of olanzapine for treating bipolar 1 disorder and schizophrenia.

According to a press release, Alkermes anticipates Lybalvi will be available for patients in the fourth quarter of this year.

“Every month, there are estimated to be about 70,000 patients switching therapy in the oral atypical market for schizophrenia and bipolar I disorder,” Hopkinson said. “Health care providers may now consider if their patients are an appropriate candidate for LYBALVI. When prescribing medications for people living with schizophrenia or bipolar I disorder, it is important to think holistically about a person’s treatment experience.”


Alkermes. Alkermes announces FDA approval of Lybalvi for the treatment of schizophrenia and bipolar 1 disorder. Accessed June 8, 2021. Available at: