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- UZEDY significantly reduced the risk of relapse by up to 80% and prolonged the time to impending relapse by up to 5.0 times while having a similar safety profile to other formulations of risperidone1,2
- The U.S. Food and Drug Administration (FDA) approved UZEDY on April 28, 2023 for the treatment of schizophrenia in adults as a subcutaneous injection every one or two months using a pre-filled syringe
- Symposia on IMPACT-TD scale for tardive dyskinesia (TD) progression measurement and clinical education tool for schizophrenia, S.C.O.P.E., are also to be presented
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that four studies across its neuroscience portfolio will be presented during the American Psychiatric Association’s (APA) 2023 Annual Meeting taking place on May 20-24, 2023. Abstracts include data for UZEDY (risperidone) extended-release injectable suspension for subcutaneous use, which was recently approved by the FDA for the treatment of schizophrenia in adults. Additional abstracts being presented include data on characteristics that impact TD diagnosis and machine-learning to identify unique patient segments for TD. TD is a chronic movement disorder that affects one in four people who take certain mental health treatments.3-5
Of the data being presented, Teva will share findings from two trials that supported the FDA approval of UZEDY, the RISE Study (The Risperidone Subcutaneous Extended-Release Study) and the SHINE Study (A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).6,7 The RISE data demonstrated that UZEDY significantly prolonged time to impending relapse by 5.0 (once-monthly dosing) and 2.7 (once-every-two-months dosing) times versus placebo in patients with schizophrenia.2 Additionally, the SHINE data confirmed the safety profile of UZEDY is consistent with other formulations of risperidone.2
“We’re pleased to present the foundational data…
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