Drug updated on 4/17/2024
| Dosage Form | Tablet (oral; 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg) |
| Drug Class | Psychotherapeutic combinations |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of Schizophrenia in adults.
- 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) in adults.
Summary
- Olanzapine and samidorphan (Lybalvi) is indicated for the treatment of Schizophrenia in adults, as well as Bipolar I disorder in adults.
- The systematic reviews/meta-analyses on Lybalvi comprised a total of 4 documents that primarily focused on its efficacy, tolerability, weight-mitigation effects and pharmacokinetics.
- In comparison to olanzapine monotherapy, olanzapine/samidorphan was associated with decreased odds of developing clinically significant weight gain and increase in waist circumference from baseline measurements among adult patients with schizophrenia.
- One study found that olanzapine was 2.7 times more likely to be associated with clinically significant weight gain compared to the combination therapy of olanzapine/samidorphan among schizophrenic patients.
- Samidorphan when used alongside olanzapine has been shown effective at reducing antipsychotic-induced weight gain; however there's insufficient evidence supporting its use for preventing cardiometabolic abnormalities induced by Olanzapin according to one review included in this analysis.
- Despite mitigating some adverse metabolic effects like excessive weight gain linked with Olanzapin alone, further studies are needed regarding patient acceptability, appropriate selection and sequencing of OLZ/SAM within treatment algorithms for adults suffering from schizophrenia or bipolar disorder-I along determining cost-effectiveness plus long-term metabolic impacts.
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 |
| 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 |