Teva Pharmaceuticals and MedinCell announced that the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq(TM), a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.

Savings on out-of-pocket costs may vary depending on the patient's insurance provider and eligibility for participation in the co-pay assistance program. UZEDY will be available in the U.S. in the coming weeks. UZEDY Clinical Trial Results The RISE study was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of risperidone extended-release injectable suspension For subcutaneous use as a treatment in patients (ages 13-65 years) with schizophrenia.

544 patients were randomized to receive a subcutaneous injection of TV-46000 once monthly (q1M), once every two months (q2M), or placebo in a 1:1:1 ratio. The primary endpoint was time to impending relapse. The second of Teva's Phase 3 studies -- SHINE(8) was designed to evaluate the use of TV-46000 subcutaneously administered q1M or q2M for up to 56 weeks in 336 patients (ages 13-65 year) with schizophrenia.

This study was completed in December 2021; results align with the findings of the RISE study. In a companion survey of study participants, 89% of patients and 92% of healthcare providers (HCPs) rated administration of UZEDY as easy when asked how easy or difficult it was to receive or administer the medication in its current form. Further, 70% of patients agreed UZEDY provided a better injection experience than their previous long-acting injectables (LAIs); 30% of patients agreed they had a better injection experience with their prior LAI medication.

Moreover, given the choice between continuing to take the clinical trial medication or returning to their previous medication, 90% of patients opted to use UZEDY.