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Poster
1574503
Impact of Treatment With TV-46000, a Long-Acting Subcutaneous Antipsychotic (LASCA), at Different Stages of Schizophrenia: a Post Hoc Analysis
Psych Congress 2023
This work was sponsored by Teva Branded Pharmaceutical Products R&D, Inc.
Introduction: This post hoc analysis assessed the efficacy and safety of TV-46000, an FDA-approved long-acting subcutaneous antipsychotic (LASCA) risperidone formulation, by schizophrenia duration and patient source.
Methods: RISE (NCT03503318) compared TV-46000 once monthly (q1m) and once every 2 months (q2m) with placebo (1:1:1). SHINE (NCT03893825) included patients who completed RISE without relapse (rollover; placebo rollover randomized [1:1] to q1m or q2m; TV-46000 rollover continued assigned treatment) or were newly recruited (de novo; randomized [1:1] to q1m or q2m).
Results: In RISE, TV-46000 prolonged time to impending relapse (hazard ratio [95% CI] vs placebo) regardless of disease duration (P=.9066 for interaction):