Olanzapine and samidorphan

(Lybalvi®)

Lybalvi®

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Drug updated on 5/17/2024

Dosage FormTablet (oral; 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg)
Drug ClassAtypical antipsychotic and opioid antagonist
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of Schizophrenia in adults.
  • Indicated for the treatment of Bipolar I disorder (acute treatment of manic or mixed episodes as monotherapy, as adjunct to lithium or valproate, or maintenance monotherapy treatment) and maintenance monotherapy treatment in adults.

Summary
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  • Olanzapine and samidorphan (Lybalvi) is indicated for the treatment of schizophrenia and Bipolar I disorder in adults. This combination has been associated with a decreased odds of developing clinically significant weight gain compared to olanzapine monotherapy, particularly in adults with schizophrenia.
  • Four systematic reviews/meta-analyses provided information about the safety, effectiveness, and considerations for specific populations or subgroups of Lybalvi.
  • The clinical efficacy of olanzapine and samidorphan remains similar to that of olanzapine alone but shows improved tolerability noted in both short-term and long-term studies. The pharmacokinetic properties are not significantly altered when these two drugs are combined.
  • There were no significant differences between the combination therapy group (olanzapine/samidorphan) and the single drug group (olanzapine) regarding weight changes during short-term treatments (<24 weeks). Additionally, all-cause dropout rates did not differ significantly, indicating comparable acceptability between both groups.
  • One study suggested potential subgroup differences where males or individuals with lower initial body mass index might experience more benefits from this combination therapy compared to using only olanzapine; however, further research is needed on this topic.
  • Compared to other antipsychotic treatments, Lybalvi presents a promising option due to its potential ability to mitigate one challenging side effect - weight gain without compromising clinical efficacy.