A phase 3 clinical trial evaluating the efficacy of extended-release injectable risperidone for patients with schizophrenia met its primary endpoint: patients who received the investigational injection showed a statistically significant delay in time to relapse, compared with those who received placebo.
Makers Teva Pharmaceuticals Industries Ltd., Tel Aviv, Israel, and MedinCell, Paris, France, announced the findings in a joint press release.
The multicenter, double-blind Risperidone Subcutaneous Extended-Release (RISE) study randomized 183 patients to subcutaneous risperidone injection monthly, 179 patients to subcutaneous risperidone injection every 2 months, and 181 patients to placebo.
Patients who received risperidone experienced a significant delay in time to relapse, compared with patients who received placebo, the study found. Those who received the injection monthly showed an 80% reduction in the risk to relapse, and those who received it every 2 months demonstrated a 62.5% drop, compared with placebo.
“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,” MedinCell chief executive officer Christophe Douat said.
The study identified no safety issues inconsistent with the safety profile of other risperidone formulations. A phase 3 study into the long-term safety and tolerability of the risperidone injection in 331 patients is ongoing, but interim results align with the safety findings of the RISE study, according to the press release.
“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-2-months treatment groups,” said Christer Nordstedt, MD, PhD, senior vice president and head of specialty clinical development at Teva. “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 [New Drug Application] submission using the currently available clinical data.”
Teva and MedinCell announce positive results for registration trial of investigational extended-release subcutaneous injectable risperidone for patients with schizophrenia [press release]. Tel Aviv, Israel; Paris, France: Teva Pharmaceuticals Industries Ltd., MedinCell; January 7, 2021.