FDA Approves a New Atypical Antipsychotic With Less Adverse Effects
June 2, 2021   

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. 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.).

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).

>> Alkermes Press Release


Correll CU et al. Am J Psychiatry. 2020;(177)12:1168-1178. Abstract

     Additional Resources:

2021 NEI Synapse: Virtual Half-Day
Chewing the Fat: Metabolic Issues in Mental Illness
CME credits: 2.0 | Date: August 28, 2021
This Month In Psychopharmacology
Olanzapine/Samidorphan Combo Found to Reduce Antipsychotic-Induced Weight Gain
Video Snippet
Practical Management of Metabolic Concerns in Your Patients
CME credit: 0.25 | Expires: March 31, 2023
Encore Presentation
Treating The Individual: Consideration Of The Safety And Tolerability Of Antipsychotics
CME credit: 0.75 | Expires: January 30, 2024
NEI Podcast
Episode 78 - (CME) Help on the Horizon: Novel Treatments in Schizophrenia

CME credit: 0.75 | Expires: July 23, 2023
Encore Presentation
Addressing the Intolerable: Practical Strategies to Mitigate Psychotropic Side Effects
CME credit: 1.0 | November 8, 2023
NEI Podcast:
Episode 108 - Novel Strategies to Treat Schizophrenia with Dr. Leslie Citrome