Teva announces publication of efficiency/safety findings for UZEDY in The Lancet

The company stated: “Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd, announced the publication of efficacy and safety findings from the phase 3 Risperidone Subcutaneous Extended-Release, or RISE, study in The Lancet Psychiatry. The data supported the FDA approval for UZEDY, which was approved in April 2023 for the treatment of schizophrenia in adults as a subcutaneous injection every one or two months using a pre-filled syringe. In RISE, UZEDY significantly prolonged time to impending relapse by 5.0 times with once-monthly dosing and 2.7 times with once-every-two-months dosing versus placebo in patients with schizophrenia, corresponding to a decreased risk of relapse by 80% and 62.5%, respectively. Study findings also show UZEDY provided clinically relevant plasma concentrations within 24 hours of administration and maintained them over the flexible dosing intervals. Additionally, the observed safety profile of UZEDY was consistent with other approved formulations of risperidone – reinforcing its potential role as an effective LAI treatment option for adults living with schizophrenia. In the RISE study, 544 patients were randomized to receive a subcutaneous injection of UZEDY once-monthly (n=183), once-every-two-months (n=180), or placebo (n=181).1 In this study population, 59% were Black or African American (n=322), 38% White (n=206), 22% were Hispanic or Latinx (n=117), 1% were Asian (n=7), less than1% were Native Hawaiian or other Pacific Islander (n=2), less than1% did not report a race (n=3), and less than1% were considered other race (n=4).”