FDA Okays New Drug Option for Schizophrenia, Bipolar I Disorder

Caroline Cassels


June 01, 2021

The US Food and Drug Administration (FDA) has approved a once-daily oral medication, which is a combination of olanzapine and samidorphan (Lybalvi, Alkermes), for the treatment of schizophrenia and bipolar I disorder.

The drug is approved for the treatment of adults with schizophrenia and for adults with bipolar I disorder, as a maintenance monotherapy or to treat acute manic or mixed episodes, as either monotherapy or an adjunct to lithium or valproate.

An atypical antipsychotic, the drug is a combination of olanzapine, an established antipsychotic medication, and samidorphan, a new chemical entity.

"Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety. Olanzapine, a highly efficacious atypical antipsychotic, is associated with significant side effects, including weight gain that may impact patients' treatment experiences and limit its use. With the efficacy of olanzapine and evidence of less weight gain in patients with schizophrenia, Lybalvi brings a welcome new addition to our medication arsenal," René S. Kahn, MD, PhD, Esther and Joseph Klingenstein professor & chair, Department of Psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai, New York City, said in a company press release.

In a clinical development program, the drug demonstrated antipsychotic efficacy, safety, and tolerability, including significantly less weight gain than olanzapine in patients with schizophrenia in the ENLIGHTEN-2 study.

The 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. Data suggest that olanzapine-associated weight gain is disease independent, the company reports.

"People living with schizophrenia or bipolar I disorder must evaluate both efficacy and tolerability when making treatment decisions," said Paul Gionfriddo, president and CEO of Mental Health America, said in the same company press release. "We are grateful that companies like Alkermes are driven to continue developing new treatment options in psychiatry that seek to address unmet needs of our community and we applaud the FDA for considering the experiences of individuals living with these conditions." 

Alkermes expects to make Lybalvi available for patients in the fourth quarter of 2021.

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