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((TM))) 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.

Automated summary

Samidorphan, developed by Alkermes, is an opioid receptor antagonist co-formulated with olanzapine into a single-dose oral tablet to reduce weight gain risk while maintaining the therapeutic effect of olanzapine. Recently approved in the USA for the treatment of schizophrenia and bipolar I disorder, olanzapine/samidorphan represents a milestone in the development of samidorphan.