FDA Approved Monthly Subcutaneous Medicine for Schizophrenia

The U.S. Food and Drug Administration (FDA) approved PERSERIS, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults.

Clinically relevant levels were reached after the first injection of PERSERIS without the use of a loading dose or any supplemental oral risperidone.

PERSERIS is not a preventive vaccine.

Maurizio Fava, MD, Executive Vice Chair of the Massachusetts General Hospital (MGH) Department of Psychiatry and an Indivior clinical research consultant, said: "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."

PERSERIS contains risperidone, a well-established treatment for schizophrenia, and uses the extended-release delivery system to form a subcutaneous (under the skin) depot that provides sustained levels of risperidone over one month.

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 formation process.

The efficacy of PERSERIS was evaluated in a pivotal Phase 3 randomized, double-blind, placebo-controlled, 8-week study of 354 patients.   

The full prescribing information, including BOXED WARNING, for PERSERIS, can be found here.

Indivior is a global specialty pharmaceutical company