Lumateperone 42 mg in an Open-Label Switch Study in Patients With Stable Schizophrenia: Results by Previous Antipsychotic

Abstract: Background: Lumateperone is an FDA-approved antipsychotic to treat schizophrenia and depressive episodes associated with bipolar I or bipolar II disorder. This analysis of open-label Study 303 investigated the safety and tolerability of lumateperone stratified by previous antipsychotic (AP) in patients who switched to lumateperone. Methods: Adult outpatients with stable schizophrenia were switched from previous AP to lumateperone 42mg once-daily for 6 weeks, then switched to another approved AP for 2 weeks follow-up. Post hoc analyses were stratified by most common AP. Safety analyses included adverse events (AE), vital signs, and laboratory tests. Results: Of the safety population (n=301), 78.1% (n=235) were previously treated with risperidone/paliperidone (n=95), quetiapine (n=60), aripiprazole/brexpiprazole (n=43), or olanzapine (n=37). Rates of treatment-emergent AEs (TEAEs) on lumateperone were similar between previous AP groups (44.2%-55.8%). TEAEs with ≥5% incidence in any AP group were dry mouth, somnolence, sedation, headache, diarrhea, cough, and insomnia. For all groups, most TEAEs were mild or moderate in severity and rates of serious TEAEs were low (0%-7.0%). Statistically significant decreases from baseline were observed in the olanzapine group in total cholesterol (PShort Description: This analysis of an open-label study investigates the safety and tolerability of lumateperone 42mg in patients with schizophrenia switching to lumateperone treatment, stratified by previous antipsychotic (AP). Treatment-emergent adverse events were mild-or-moderate in severity and rates were similar between previous AP groups. Significant decreases from baseline were observed in cardiometabolic parameters for 2 previous AP groups. In outpatients with stable schizophrenia, lumateperone 42mg treatment was well tolerated in patients switching from a variety of APs.Name of Sponsoring Organization(s): Intra-Cellular Therapies, Inc.