Teva to Present Data Demonstrating UZEDY™ (risperidone) Extended-Release Injectable Suspension Significantly Prolonged Time to Impending Relapse for Adults with Schizophrenia at the American Psychiatric Association’s 2023 Annual Meeting
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 that supported the FDA’s approval of UZEDY,an important new treatment option for adults with schizophrenia,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “We know schizophrenia patients experience a number of challenges when it comes to this condition, and are optimistic that UZEDY can help address the unmet needs of patients, their caregivers, and physicians.”
Findings from the RISE and SHINE studies demonstrate that UZEDY is efficacious with the known safety profile of risperidone. The innovative long-acting formulation of UZEDY allows for both absorption and sustained release after subcutaneous injection and is available with a range of dosing options. UZEDY utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell, that controls the rate and duration of risperidone release. With this delivery system, therapeutic blood concentrations are reached within 6-24 hours of a single dose.1
In addition to the data, Teva will also be holding a symposium on the newly developed IMPACT-TD scale, featuring Richard Jackson, MD, Assistant Clinical Adjunct Professor, University of Michigan School of Medicine Department of Psychiatry, that may help better measure disease progression of those living with TD by taking a holistic approach to tracking social, vocational, psychological and psychiatric challenges the condition poses over time. A symposium on S.C.O.P.E. featuring John Kane, MD, Professor and Chairman, Department of Psychiatry, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, will also be presented – an educational tool for schizophrenia that helps teach physicians about common myths and misconceptions, manage frequent clinical dilemmas and identify the latest therapeutic options.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at www.tevapharm.com.