
The Phase 3 Risperidone Subcutaneous Extended-release (RISE) study assessed the efficacy of TV-46000, a long-acting, subcutaneous antipsychotic combining risperidone with innovative drug delivery. The study included a 12-week oral risperidone stabilization phase and a randomized, double-blind, placebo-controlled, subcutaneous TV-46000 relapse-prevention phase. TV-46000, administered monthly or every 2 months, significantly delayed impending relapse in schizophrenia patients compared to placebo. Common adverse events included injection site nodules and weight increase, with a safety profile consistent with approved risperidone formulations.
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