TV-46000 Demonstrates Prolonged Schizophrenia Relapse Prevention, SHINE Study Finds

TV-46000, a long-acting subcutaneous antipsychotic (LASCA), exhibits a favorable long-term benefit-risk profile for patients with schizophrenia, according to study results presented in a poster at Psych Congress 2023 in Nashville, Tennessee.

The study, designated as Patients With Schizophrenia (SHINE) (NCT03893825), sought to evaluate the extended benefits of TV-46000 in this population, and builds on the results from the Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia (RISE) trial, which demonstrated the drug's ability to significantly extend the time to impending schizophrenia relapse.

Patients from the RISE trial who hadn't experienced a relapse (rollover) and newly recruited patients (de novo) were included in the study. The de novo and placebo rollover cohorts were randomly assigned to receive TV-46000 either once monthly (q1m) or once every 2 months (q2m) for up to 56 weeks, while the TV-46000 rollover cohort continued with their assigned regimen.

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With 334 patients participating in the study receiving TV-46000 q1m or q2m, researchers accumulated a total of 202.3 patient-years of TV-46000 treatment data. Adverse events reported for over 5% of patients included injection site pain, with some variation in different cohorts. Serious adverse events were reported for a minority of patients, including worsening schizophrenia and hyperglycemia.

Kaplan-Meier estimates for remaining relapse-free at week 56 were 0.98 (2%) risk for q1m and 0.88 (12%) risk q2m, indicating the drug's effectiveness in preventing relapse.

“Patient-centered outcomes improved for both TV-46000 treatment groups,” authors wrote in the poster. “SQLS improved for q1m (least-squares mean change [SE], −2.16 [0.98]) and q2m (−0.43 [0.98]); other PCOs (5-Level EuroQoL 5-Dimensions Questionnaire, Personal and Social Performance Scale, Drug Attitudes Inventory 10-item version) remained stable.”

Teva Branded Pharmaceutical Products R&D, Inc. sponsored the study.

Reference

Franzenbur K, et al. Long-term safety, tolerability, and effectiveness of TV-46000, a long-acting subcutaneous antipsychotic (LASCA), in patients with schizophrenia (SHINE). Poster presented at Psych Congress; September 6-10, 2023; Nashville, Tennessee.