Olanzapine/Samidorphan: First Approval

Samidorphan, which was developed by Alkermes, is an opioid receptor antagonist that has been co-formulated with olanzapine into a single-dose oral tablet to mitigate the risk of weight gain while providing the therapeutic effect of olanzapine. Olanzapine/samidorphan (LYBALVI™) was recently approved in the USA for the treatment of schizophrenia and bipolar I disorder. This article summarizes the milestones in the development of samidorphan leading to this first approval of olanzapine/samidorphan.