Indivior: FDA Approves PERSERIS For Schizophrenia In Adults

(RTTNews) - Indivior PLC (INDV.l) announced that FDA has approved PERSERIS, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for 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.

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.

Schizophrenia is a devastating, chronic and often disabling mental health condition that impacts the lives of people suffering from this illness, their families and caregivers.

The efficacy of PERSERIS was evaluated in a pivotal Phase 3 randomized, double-blind, placebo-controlled, 8-week study of 354 patients (NCT 02109562).

The safety of PERSERIS was evaluated in 814 adults with schizophrenia who received at least one dose of PERSERIS during clinical trials.

The most common systemic adverse reactions in the pivotal Phase 3 trial (in =5% of PERSERIS patients and greater than twice placebo) were increased weight, sedation/somnolence and musculoskeletal pain. The most common injection site reactions (=5% of all patients across PERSERIS and placebo groups) were injection site pain and reddening of the skin.