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Lybalvi FDA Approval History

Last updated by Judith Stewart, BPharm on June 2, 2021.

FDA Approved: Yes (First approved May 28, 2021)
Brand name: Lybalvi
Generic name: olanzapine and samidorphan
Dosage form: Tablets
Company: Alkermes, Inc.
Treatment for: Schizophrenia, Bipolar Disorder

Lybalvi (olanzapine and samidorphan) is a combination of an established antipsychotic agent (olanzapine) and a novel μ-opioid receptor antagonist (samidorphan) for the treatment of schizophrenia and bipolar I disorder.

  • Lybalvi is designed to provide the efficacy of olanzapine while limiting the weight gain often associated with olanzapine therapy. In clinical studies, patients treated with Lybalvi demonstrated statistically significantly less weight gain than patients treated with olanzapine.
  • Lybalvi is taken once daily with or without food.
  • The Lybalvi product label carries a boxed warning for increased risk of cerebrovascular adverse reactions in elderly patients with dementia related psychosis.
  • The samidorphan contained in Lybalvi blocks the effects of opioids. Because of the risk of life-threatening opioid overdose, Lybalvi is contraindicated in patients who are using opioids, and patients who are undergoing acute opioid withdrawal. Prior to starting Lybalvi, there should be at least a 7 day opioid-free interval from last use of short-acting opioids, and a 14 day opioid-free interval from the last use of long-acting opioids. Patients should not start taking opioids for at least 5 days after stopping treatment with Lybalvi.
  • Common adverse reactions seen in patients with schizophrenia include increased weight, somnolence, dry mouth, and headache. Common adverse reactions seen in patients with bipolar I disorder include asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, and tremor.

Development Timeline for Lybalvi

DateArticle
Jun  1, 2021Approval  FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder
Dec 29, 2020FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831
Nov 17, 2020Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review
Oct  9, 2020FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder
Jan 28, 2020Alkermes Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder
Nov 19, 2019Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder
Jul 15, 2019Alkermes Expands Planned New Drug Application for ALKS 3831 to Include Treatment of Bipolar I Disorder
Nov 29, 2018Alkermes Announces Positive Topline Results From ENLIGHTEN-2 Phase 3 Study of ALKS 3831 in Patients With Schizophrenia

Further information

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