The FDA has approved PERSERISTM (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults PERSERIS is the first once-monthly subcutaneous risperidone-containing long-acting injectable
The efficacy of PERSERIS was evaluated in a pivotal Phase 3 randomized, double-blind, placebo-controlled, 8-week study of 354 The safety of PERSERIS was evaluated in 814 adults with schizophrenia who received at least one dose of PERSERIS during clinical trials. A total of 322 patients were treated with PERSERIS for at least six months, with 234 of those treated with PERSERIS for at least 12 months. The systemic safety profile of PERSERIS was consistent with the known safety profile of oral risperidone. The most common systemic adverse reactions in the pivotal Phase 3 trial (in ≥5% of PERSERIS patients and greater than twice placebo) were increased weight, sedation/somnolence and musculoskeletal pain. The most common injection site reactions (≥5% of all patients across PERSERIS and placebo groups) were injection site pain and reddening of the skin.