FDA Approves Long-Acting Risperidone Formulation

Perseris, a once-monthly long-acting injectable (LAI) form of risperidone, has been approved by the Food and Drug Administration for the treatment of schizophrenia in adults. Perseris uses an extended-release delivery system that allows patients to achieve clinically relevant levels of the drug without the need for a loading dose or supplemental oral risperidone.

According to Indivior, the manufacturer of Perseris, the efficacy of this LAI was demonstrated in a phase 3 randomized, double-blind, placebo-controlled, eight-week study of 354 patients. That study found a statistically significant improvement in the primary clinical endpoint (Positive and Negative Syndrome Scale total score) at day 57. The improvement in Clinical Global Impression Severity of Illness was also statistically significant at day 57.  

The safety profile of Perseris was consistent with that of oral risperidone. The most common systemic adverse reactions in the phase 3 trial were increased weight, sedation/somnolence, and musculoskeletal pain. Prescribing information is available online. ■