FDA OKs Once-Monthly Risperidone Injection for Schizophrenia

Megan Brooks


July 30, 2018

The US Food and Drug Administration has approved the first once-monthly subcutaneous injection of risperidone (Perseris, Indivior) for the treatment of schizophrenia in adults.

Perseris uses an extended-release delivery system to form a subcutaneous depot that provides sustained levels of risperidone over 1 month. Clinically relevant levels of the drug are reached after the first injection without use of a loading dose or any supplemental oral dose of risperidone, the company noted in a press release.

"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' symptom severity," Maurizio Fava, MD, executive vice chair of the Department of Psychiatry, Massachusetts General Hospital, and Indivior clinical research consultant, said in the 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," said Fava.

The efficacy of once-monthly subcutaneous risperidone injection was demonstrated in a phase 3 randomized, double-blind, placebo-controlled, 8-week study of 354 patients. The study showed a statistically significant improvement in the Positive and Negative Syndrome Scale total score and the Clinical Global Impression Severity of Illness at day 57. The clinical trials of Perseris were designed for the antipsychotic to be started without a loading dose or any supplemental risperidone, the company said.

The systemic safety profile of Perseris was consistent with the known safety profile of oral risperidone. The most common systemic adverse reactions were increased weight, sedation/somnolence, and musculoskeletal pain. The most common injection site reactions were injection site pain and reddening of the skin.

Perseris has a boxed warning noting that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk for death. Perseris is not approved for use in patients with dementia-related psychosis. Full prescribing information is available online.

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