Lybalvi® (olanzapine and samidorphan) is now available for the treatment of schizophrenia in adults and for bipolar I disorder in adults for acute treatment of manic or mixed episodes as monotherapy and as an adjunct to lithium or valproate, as well as maintenance monotherapy treatment.

Lybalvi is an atypical antipsychotic comprised of samidorphan, a mu-opioid receptor antagonist, co-formulated with the established antipsychotic agent olanzapine, in a single bilayer tablet. The once-daily oral formulation is designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.

The approval was based on data from the phase 3 ENLIGHTEN-1 (ClinicalTrials.gov Identifier: NCT02634346) and ENLIGHTEN-2 (ClinicalTrials.gov Identifier: NCT02694328) studies in adults with schizophrenia. Approval for the treatment of bipolar I disorder was supported by the established efficacy and safety profile of orally administered olanzapine in adequate and well-controlled studies.

Lybalvi is supplied in 4 strengths of olanzapine/samidorphan: 5mg/10mg, 10mg/10mg, 15mg/10mg, and 20mg/10mg. The tablet should not be divided or combined with other strengths.


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Lybalvi is contraindicated in patients using opioids or undergoing acute opioid withdrawal. In these patients, treatment should be delayed for a minimum of 7 days after the last use of short-acting opioids and 14 days after the last use of long-acting opioids.

For patients who have a higher risk of hypotensive reactions, are at risk of slower olanzapine metabolism, or may be more pharmacodynamically sensitive to olanzapine, the recommended starting dosage is 5mg/10mg once daily; in these patients, if dose escalation is necessary, the dosage should be increased slowly.

Alkermes is providing cost support for Lybalvi though a co-pay savings program for commercially insured eligible patients as well as a patient assistance program for uninsured patients who meet eligibility requirements.

Reference

Alkermes announces commercial availability of Lybalvi® for the treatment of schizophrenia and bipolar I disorder. News release. October 18, 2021. https://www.prnewswire.com/news-releases/alkermes-announces-commercial-availability-of-lybalvi-for-the-treatment-of-schizophrenia-and-bipolar-i-disorder-301401658.html.