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Olanzapine/Samidorphan: First Approval

Version 3 2021-08-04, 05:23

Version 2 2021-08-04, 05:12

Version 1 2021-08-04, 05:04

online resource

posted on 2021-08-04, 05:23 authored by Julia Paik

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest Julia Paik is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability not applicable

Additional information about this Adis Drug Review can be found here

Abstract

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.