FDA Approves Extended-Release Injectable Suspension for Schizophrenia

Officials with the FDA have approved risperidone (Perseris, Indivior) for extended-release injectable suspension for the treatment of schizophrenia in adults, according to a press release.

Risperidone is the first once-monthly subcutaneous risperidone-containing, long-acting injectable. Initial peak risperidone plasma levels occur within 4 to 6 hours of dosing and are due to an initial release of the drug during the depot formulation process, according to Indivior.

The approval is based on data from a phase 3 trial evaluating the efficacy and safety of risperidone. In an 8-week study of 354 patients, efficacy was demonstrated by an improvement in the primary clinical endpoint, Positive and Negative Syndrome Scale total score at day 57. There was also a statistically significant improvement in Clinical Global Impression Severity of Illness at day 57.

According to the press release, clinically relevant levels were reached after the first injection without use of a loading dose or any supplemental oral risperidone.

Risperidone’s safety was evaluated in 814 adults with schizophrenia who received at least 1 dose of the treatment during clinical trials, with 322 patients who were treated with risperidone for at least 6 months and 234 who were treated with risperidone for at least 12 months. The systemic safety profile of risperidone was consistent with the known safety profile of oral risperidone, according to the press release.

Related Coverage: FDA Approves New Treatment Regimen for Schizophrenia

“Treatment adherence is a major challenge in schizophrenia due to the complexity of the disease. It is important to have additional treatment options available to physicians to help them improve their patients’ symptoms of severity,” Maurizio Fava, executive vice chair of the Massachusetts General Hospital Department of Psychiatry and Indivior clinical research consultant, said in a press release. “The studies carried out by Indivior suggest that Perseris may offer patients, caregivers, and physicians a new once-monthly subcutaneous medication option to treat adults with schizophrenia.”

The most common systemic adverse effects associated with risperidone were increased weight, sedation/somnolence, and musculoskeletal pain.

Reference

FDA Approves PERSERIS™ (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults [news release]. Indivior’s website. http://indiviormedia.com/#restoftext. Accessed July 30, 2018.