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Olanzapine and samidorphan

(Lybalvi®)

Lybalvi®

Drug updated on 10/25/2024

Dosage FormTablet (oral; olanzapine/samidorphan: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg and 20 mg/10 mg)
Drug ClassAtypical antipsychotic and opioid antagonists
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.

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Summary
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  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • The combination of olanzapine and samidorphan (OLZSAM) demonstrated comparable efficacy to olanzapine alone in reducing Positive and Negative Syndrome Scale (PANSS) scores in patients with schizophrenia (SMD = 0.04; 95% CI (RR) = -0.09 to 0.17).
  • OLZSAM showed potential in mitigating olanzapine-induced weight gain, with a reduction of 1.0 kg reported in some studies. However, the overall weight change difference between OLZSAM and olanzapine was not statistically significant in a meta-analysis (SMD = -0.19, 95% CI - 0.45 to 0.07).
  • There is a notable lack of data regarding humanistic and behavioral outcomes, such as interpersonal relations and treatment adherence, particularly for OLZSAM, which presents an important gap in the literature.
  • The proportion of patients experiencing at least one adverse event was similar between the OLZSAM and olanzapine groups (RR (4 RCTs, RR = 1.02, 95% CI 0.84 to 1.23, I(2) = 0.99; 95% CI = 0.90-1.09; p = 0.81), indicating no significant difference in overall adverse event rates.
  • The incidence of drug discontinuation due to adverse events was higher in the OLZSAM group compared to olanzapine alone (RR = 1.22; 95% CI = 0.84-1.79; p = 0.30), although this was not statistically significant.
  • The effect of samidorphan in preventing olanzapine-induced weight gain was more pronounced in patients with a lower initial body mass index (BMI) and in females, suggesting that gender and BMI may influence the treatment outcomes for weight gain mitigation in patients with schizophrenia and bipolar disorder type 1.