Drug updated on 5/17/2024
Dosage Form | Tablet (oral; 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg) |
Drug Class | Atypical 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.
Latest News
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Summary
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Lybalvi (olanzapine and samidorphan) Prescribing Information. | 2023 | Alkermes Inc., Waltham, MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Olanzapine and samidorphan combination treatment: a systematic review. | 2022 | Journal of Affective Disorders |
Opioid antagonists to prevent olanzapine-induced weight gain: a systematic review. | 2022 | The Mental Health Clinician |
[Corrigendum] to "Olanzapine and samidorphan combination treatment: a systematic review". Journal of Affective Disorders. Volume 301, 15 March 2022, Pages 99-106. | 2022 | Journal of Affective Disorders |
A meta‑analysis comparing short‑term weight and cardiometabolic changes between olanzapine/samidorphan and olanzapine. | 2021 | Scientific Reports |
New antipsychotic medications in the last decade. | 2021 | Current Psychiatry Reports |