Safety and Exposure of TV-46000, a Long-Acting Subcutaneous Antipsychotic (LASCA) Formulation of Risperidone, in Adolescent and Young Adult Patients With Schizophrenia: Results From the Phase 3 RISE and SHINE Studies

Abstract: Background: Two phase 3 trials evaluating TV-46000 for schizophrenia enrolled patients aged 13–65 years. Adolescents aged 13–18 years and young adults aged 19–21 years who received TV-46000 in these studies are included in this safety analysis. Methods: RISE (NCT03503318) compared the efficacy and safety of once monthly (q1m) or once every 2 months (q2m) subcutaneous TV-46000 vs placebo in patients with schizophrenia who underwent stabilization on oral risperidone. SHINE (NCT03893825) was an extension study for patients who completed RISE without relapse and de novo patients stabilized on oral risperidone before randomization. Results: Adolescents (n=4) were aged 16 years and female. They received TV-46000 50 mg q1m (n=1) or 100 mg q2m (n=3); mean (range) exposure was 21.38 (8.1–36.4) weeks. Two patients experienced 3 mild/moderate adverse events (AEs; insomnia and sedation (n=1) and psychotic disorder [n=1]) and 1 severe AE (depression). Young adult patients (n=9; 2 female, 7 male) were aged 19–20 years and received placebo (n=1), or TV-46000 50 mg (n=1), 75 mg (n=2), or 100 mg (n=1) q1m or 100 mg (n=1) or 200 mg q2m (n=3); mean (range) TV-46000 exposure was 67.16 (8.14–112.00) weeks. Five patients experienced 13 mild/moderate AEs on TV-46000 (headache [n=2], anxiety [n=1], extrapyramidal disorder [n=2], dystonia [n=2], blepharospasm [n=1], akathisia [n=1], nasal congestion [n=1], nasopharyngitis [n=2], urinary tract infection [n=1]), and 1 severe AE (exacerbation of schizophrenia). Conclusions: Among adolescents and young adults who received TV-46000 in these studies, no unexpected safety findings, or clinically meaningful trends in AEs were observed.Short Description: The phase 3 trials RISE (NCT03503318) and SHINE (NCT03893825) Phase 3 trials evaluated TV-46000 in patients aged 13–65 years with schizophrenia. Adolescents aged 13–18 years and young adults aged 19–21 years who received TV-46000 in these studies are included in this safety analysis. Among adolescents and young adults who received TV-4600 in these studies, no unexpected safety findings or clinically meaningful trends in AEs were observed.Name of Sponsoring Organization(s): Teva Branded Pharmaceutical Products, R&D, Inc.