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The RISE study results look promising.
Teva Pharmaceuticals and MedinCell announced positive results for the risperidone subcutaneous extended-release study (RISE study), a phase 3 clinical trial evaluating the efficacy of risperidone extended-release injectable suspension for subcutaneous use as a treatment for patients with schizophrenia.
“Schizophrenia is a chronic, progressive and severe mental disorder in which every relapse has the potential to cause cognitive and psychosocial loss, worsen long-term outcomes, and increase the overall burden for patients, caregivers, families, and the healthcare system. We are encouraged by the results of the RISE study, which demonstrated a marked delay in time to relapse for patients in both the monthly and once-every-two months treatment groups,” Christer Nordstedt, MD, PhD, Senior Vice President, Head of Specialty Clinical Development at Teva said to the press. “We look forward to sharing more detailed results from the RISE study at future scientific conferences, in peer-reviewed publications as well as exploring options for a potential NDA submission using the currently available clinical data.”1
Trial enrollment was open to participants 13 to 65 years of age. Those treated with the investigational subcutaneous risperidone injection either monthly or once every 2 months experienced a statistically significant delay in time to relapse compared to participants who received the placebo.
“Long-acting injectables (LAI) for schizophrenia are considered to be an innovative treatment option that we believe will make a meaningful difference, yet they tend to be underutilized and only introduced late in the course of the disease,” said MedinCell CEO Christophe Douat. “The results of the RISE study are promising and point to the potential for risperidone to be a subcutaneously administered treatment option for patients with schizophrenia.”1
Teva intends to continue leading the clinical development and regulatory process, as well as maintaining responsibility for commercialization of this treatment.
1. Teva Pharmaceuticals Industries. Teva and MedinCell Announce Positive Results for Registration Trial of Investigational Extended-Release Subcutaneous Injectable Risperidone for Patients with Schizophrenia. News release. Businesswire. January 7, 2021. https://www.businesswire.com/news/home/20210107005469/en/Teva-and-MedinCell-Announce-Positive-Results-for-Registration-Trial-of-Investigational-Extended-Release-Subcutaneous-Injectable-Risperidone-for-Patients-with-Schizophrenia