FDA Approves Olanzapine, Samidorphan Combination for Treatment of Schizophrenia, Bipolar I Disorder

The oral combination olanzapine and samidorphan (Lybalvi) has been approved by the FDA for the treatment of adults with schizophrenia or bipolar I disorder as a maintenance monotherapy or for the acute treatment of manic or mixed episodes.

According to a press release from Alkermes, the medication has the same established antipsychotic efficacy of olanzapine with less weight gain. The once-daily, oral atypical antipsychotic could represent a much-needed new treatment for schizophrenia and bipolar I disorder.

“Schizophrenia and bipolar I disorder are complex, chronic diseases and there remains a persistent need for new medications with proven efficacy and safety,” said Rene S. Kahn, MD, PhD, chair of the Department of Psychiatry and Behavioral Health System at the Icahn School of Medicine at Mount Sinai, in the press release. “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.”

The treatment demonstrated antipsychotic efficacy, safety, and tolerability in the ENLIGHTEN clinical development program, according to the press release. The results included a more statistically significant reduction in weight gain than olanzapine in patients with schizophrenia, and the results are included in the approved labeling for Lybalvi.

The ENLIGHTEN-1 trial evaluated Lybalvi compared to placebo over 4 weeks in 403 patients experiencing an acute exacerbation of schizophrenia. According to the press release, Lybalvi demonstrated statistically significant reductions from baseline in Positive and Negative Syndrome Scores compared to placebo. The most common adverse events included weight gain, somnolence, and dry mouth.

Similarly, the ENLIGHTEN-2 trial evaluated the weight gain profile of Lybalvi compared to olanzapine over 6 months in 561 patients with stable schizophrenia. Investigators saw a lower mean percent weight gain from baseline at 6 months compared to the olanzapine group and a lower proportion of patients who gained 10% or more of their baseline body weight at 6 months compared to the olanzapine group.

Officials with the FDA approved Lybalvi based on data from 27 clinical studies, including 18 evaluating Lybalvi and 9 evaluating samidorphan alone. According to the press release, the drug should be available for patients in the fourth quarter of 2021.

“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,” Kahn concluded in the press release.

REFERENCE

Alkermes Announces FDA Approval of Lybalvi for the Treatment of Schizophrenia and Bipolar I Disorder. News release. Alkermes; June 1, 2021. Accessed June 2, 2021. https://investor.alkermes.com/news-releases/news-release-details/alkermes-announces-fda-approval-lybalvitm-treatment