Uzedy extended-release injectable approved by FDA for treatment of Schizophrenia

April 28, 2023

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell (Euronext: MEDCL) 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™, 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. Approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment, most commonly due to suboptimal adherence to treatment with oral antipsychotics. Each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.

Schizophrenia is a chronic, progressive, and severely debilitating mental health disorder that affects how one thinks, feels, and acts. The use of novel SteadyTeq technology in Uzedy controls the release of risperidone over time. The initiation of treatment requires no loading dose or oral supplementation. Therapeutic blood concentrations are reached within 6-24 hours of a single dose. Actual costs for individual patients are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply.

Uzedy will be available in the U.S. on May 17, 2023. WAC is approximately $3,080.00 per month (at a
dose of 125mg per month).

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