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FDA Approves Treatment for Adults With Schizophrenia and Bipolar I Disorder
The US Food and Drug Administration has approved Alkermes Plc's LYBALVI (olanzapine and samidorphan) to treat adults with schizophrenia and adults with bipolar I disorder. The drug offers the antipsychotic efficacy of olanzapine with less weight gain.
Olanzapine and samidorphan, a once-daily, oral atypical antipsychotic, is approved as monotherapy for acute treatment of manic or mixed episodes or as an adjunct to lithium or valproate.
LYBALVI is composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity.
Alkermes plans to have the new medicine available to patients and clinicians in the fourth quarter of 2021.
"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," said René S. Kahn, MD, PhD, Department of Psychiatry and Behavioral Health System, Icahn School of Medicine at Mount Sinai, New York, New York. "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."
The ENLIGHTEN clinical development program analyzed LYBALVI and included 2 key studies in 964 patients with schizophrenia published in The Journal of Clinical Psychiatry and the American Journal of Psychiatry. The FDA approval of olanzapine and samidorphan involved data from 27 clinical studies, 18 of which evaluated LYBALVI.
LYBALVI will carry a black box warning about increased mortality in elderly patients with dementia-related psychosis and will come with contraindications for patients taking opioids or undergoing acute opioid withdrawal.
—Meagan Thistle
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