(#47) Real-World Clinical Outcomes Among Patients Receiving the Long-Acting Injectable Antipsychotic TV-46000 Versus Second-Generation Oral Antipsychotics

Abstract: Background: TV-46000 is a long-acting subcutaneous injectable form of risperidone for the treatment of schizophrenia in adults. This retrospective study compared clinical outcomes among adults with schizophrenia who received TV-46000 versus any second-generation oral antipsychotic (SGOA) or oral risperidone. Methods: Kythera closed-claims database data (study period: May 1, 2021óOctober 31, 2024) from patients aged ?18 years with schizophrenia who were continuously enrolled in Medicaid, Medicare, or commercial health plans for 2 years before and 6 months after TV-46000 or SGOA prescription were included. Patients were propensity-score matched based on demographic and medical history variables. Relapse was defined as the first schizophrenia-related emergency department/inpatient visit resulting in hospitalization. Results: For TV-46000 (n=720) versus SGOAs (n=720) or oral risperidone (n=720), relapse rate was 9.0% versus 15.4% (P=.0089) and 16.8% (P=.0019), respectively; mean time to relapse was 94 days versus 61 days (P=.0003) and 69 days (P=.0040). All-cause rehospitalization rates at 30 days were 7.2% versus 9.2% and 9.0%. Discontinuation rate with TV-46000 versus SGOAs or oral risperidone was 34.9% versus 39.2% (P=.2316) and 43.1% (P=.0242), and mean time to discontinuation was 67 days versus 50 days (PShort Description: This retrospective, cohort-claims database study compared clinical outcomes among adult patients with schizophrenia who received the long-acting injectable antipsychotic medication TV-46000 versus those who received second-generation oral antipsychotics (SGOAs) or oral risperidone. Treatment with TV-46000 demonstrated lower relapse rates and longer time to relapse versus SGOAs and oral risperidone, as well as lower discontinuation rates versus oral risperidone and longer time to discontinuation versus SGOAs.Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products R&D LLC.