Once-monthly risperidone injectable for schizophrenia

September 14, 2018 0 By CH Unnikrishnan

The USFDA has approved Perseris, a once-monthly subcutaneous risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults.

Clinically relevant levels were reached after the first injection of Perseris without use of a loading dose or any supplemental oral risperidone, according to Indivior PLC, the maker of the drug.

Risperidone is a well-established treatment for schizophrenia, and uses the extended-release delivery system to form a subcutaneous 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 safety of Perseris was evaluated in 814 adults with schizophrenia. A total of 322 patients were treated with Perseris for at least six months, with 234 of those treated for at least 12 months. The systemic safety profile of the drug was consistent with the known safety profile of oral risperidone.

The most common systemic adverse reactions in the pivotal Phase 3 trial were increased weight, sedation/somnolence and musculoskeletal pain.