The Food and Drug Administration has approved Perseris, a once-monthly, long-acting injectable formulation of risperidone, for the treatment of schizophrenia in adults, according to a press release from the drug’s developer, Indivior.
The depot formulation of the atypical antipsychotic, administered subcutaneously, provides sustained levels of risperidone for 1 month; the process of injecting it also releases some of the drug, which helps achieve peak plasma levels within the first 4-6 hours. There is no need for either loading doses or supplemental oral doses with Perseris.
Efficacy was based on a phase 3, randomized, double-blind, placebo-controlled, 8-week study of 354 patients. The primary endpoint was improvement in Positive and Negative Syndrome Scale by day 57. Safety was evaluated in 814 patients who had participated in clinical trials of Perseris and was in line with the known safety profile of risperidone.
The most common adverse reactions, occurring in more than 5% of patients, were increased weight, sedation/somnolence, and musculoskeletal pain. Other risks included neuroleptic malignant syndrome, tardive dyskinesia, and hyperprolactinemia. Full prescribing information can be found on the manufacturer’s website.