Olanzapine-samidorphan combination tablets for the treatment of schizophrenia and bipolar I disorder - what is it, and will it be used?

Expert Rev Neurother. 2022 May;22(5):365-376. doi: 10.1080/14737175.2022.2060742. Epub 2022 Apr 13.

Abstract

Introduction: Although olanzapine remains one of the most efficacious antipsychotic medications for the treatment of schizophrenia, there are significant tolerability concerns related to its weight and metabolic profile. Olanzapine-samidorphan combination tablets (OLZ/SAM), branded as Lybalvi, is a newly FDA approved formulation aimed at attenuating antipsychotic induced weight gain via modulation of the endogenous opioid system with samidorphan, while retaining the robust antipsychotic efficacy of olanzapine.

Areas covered: We reviewed the published literature of OLZ/SAM for the management of schizophrenia using the US National Library of Medicine's PubMed.gov resource. Topics covered in this narrative review include the pharmacokinetics, pharmacodynamics, efficacy, and tolerability of OLZ/SAM.

Expert opinion: OLZ/SAM is an effective and well-tolerated pharmacologic option in mitigating olanzapine induced weight gain while retaining olanzapine's efficacy. OLZ/SAM cumulatively tends to attenuate weight gain rather than promote weight loss. Effect on metabolic laboratory variables appears limited. Additional research will be needed to determine its effectiveness compared to alternative strategies to attenuate antipsychotic induced weight gain.

Keywords: Olanzapine; antipsychotic; bipolar disorder; lybalvi; metabolic syndrome; samidorphan; schizophrenia; weight gain.

Publication types

  • Review

MeSH terms

  • Antipsychotic Agents* / pharmacology
  • Antipsychotic Agents* / therapeutic use
  • Benzodiazepines / therapeutic use
  • Bipolar Disorder* / drug therapy
  • Humans
  • Naltrexone / analogs & derivatives
  • Narcotic Antagonists / pharmacology
  • Narcotic Antagonists / therapeutic use
  • Olanzapine / pharmacokinetics
  • Olanzapine / therapeutic use
  • Schizophrenia* / drug therapy
  • Tablets / therapeutic use
  • Weight Gain

Substances

  • Antipsychotic Agents
  • Narcotic Antagonists
  • Tablets
  • Benzodiazepines
  • Naltrexone
  • 3-carboxamido-4-hydroxynaltrexone
  • Olanzapine