The US Food and Drug Administration (FDA) announced their approval of Alkermes’ LYBALVI, a combination of olanzapine and samidorphan, for the treatment of adults with schizophrenia and/or bipolar I disorder. LYBALVI is a once-daily, oral atypical antipsychotic that works as a maintenance monotherapy for the acute treatment of manic or mixed episodes, or as an adjunct to lithium or valproate.
Olanzapine (OLZ) is a dopamine D2 receptor antagonist, and samidorphan (SAM) is an opioid receptor antagonist. This combination treatment of OLZ/ SAM caused significantly less weight gain in patients with schizophrenia and bipolar I disorder.
In the ENLIGHTEN clinical development program, the novel antipsychotic demonstrated efficacy, safety, and tolerability. Most notably, patients taking LYBALVI experienced statistically significant less weight gain than OLZ in patients with schizophrenia in the ENLIGHTEN-2 study (Figure.).
. Olanzapine/samidorphan treatment is associated with decreased risk of ≥ 10% weight gain (50% decrease in risk), ≥ 7% weight gain (50% decrease in risk), and ≥ 5 cm increase in waist circumference (47% decrease in risk) from baseline at 24 weeks, compared to olanzapine monotherapy (Correll et al, 2020
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Correll CU et al. Am J Psychiatry. 2020;(177)12:1168-1178.