The US FDA has approved Uzedy (risperidone) extended-release injectable suspension for the treatment of adults with schizophrenia
The approval was based on the results from the 2 P-III study (RISE) & (SHINE) evaluating the efficacy of risperidone extended-release injectable suspension for SC use in 544 & 336 patients aged 13-65yrs. with schizophrenia. The results showed that the patients treated with Uzedy achieved a ~80% reduction in risk of schizophrenia relapse over PBO
Uzedy, the first SC, long-acting formulation of risperidone that has been developed using SteadyTeq (copolymer technology) to MedinCell that controls the steady release of risperidone
Ref: Businesswire | Image: Teva
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