Long-Acting Risvan Approved for Schizophrenia Treatment

The Food and Drug Administration (FDA) has approved Risvan^® (risperidone for extended-release injectable suspension) for the treatment of adults with schizophrenia.

Risvan contains risperidone, an atypical antipsychotic, in a suspension delivery system. Following intramuscular (IM) injection, it forms a depot that provides sustained plasma levels over the monthly interval. 

The approval was based on data from the 12-week randomized, double-blind, placebo-controlled phase 3 PRISMA-3 study (ClinicalTrials.gov Identifier: NCT03160521). The study evaluated the efficacy and safety of IM injections of Risvan in adults with acute exacerbation of schizophrenia. 

Study participants were randomly assigned 1:1:1 to receive Risvan 75mg, 100mg, or placebo IM every 4 weeks for a total of 3 doses. The primary endpoint was the mean change in Positive and Negative Syndrome Scale (PANSS) total score from day 1 (baseline) to day 85 (or the last post baseline assessment).

Results showed the trial met its primary endpoint demonstrating a statistically significant improvement in PANSS total score at day 85 with Risvan 75mg (mean adjusted difference, -13.0 [95% CI, -17.3, -8.8]; P <.0001) and Risvan 100mg (mean adjusted difference, -13.3 [95% CI, -17.6, -8.9]; P <.0001) compared with placebo. 

Additionally, both Risvan treatment groups demonstrated statistically significantly better Clinical Global Impression-Severity scores (secondary endpoint) vs placebo. No new safety signals were reported during the trial.

Risvan for extended-release injectable suspension is supplied as a single-dose kit containing 75mg and 100mg of risperidone. The product is administered as an IM injection in the gluteal or deltoid muscle by a health care professional. Prior to initiating treatment with Risvan, tolerability with oral risperidone should be established.