Study: Subcutaneous Injectable Risperidone Improves Outcomes for Certain Patients With Schizophrenia
Subcutaneous injectable risperidone (TV-46000/mdc-IRM, Teva Pharmaceuticals) prolonged the time to relapse, decreased the proportions of patients with schizophrenia who experienced impending relapse at week 24, and demonstrated significant increase in proportions maintaining stability for patients with schizophrenia who underwent stabilization on oral risperidone, according to the results of the phase 3 RISE study. The trial randomized patients to receive TV-46000 once monthly (q1m), TV-46000 once every 2 months (q2m), or placebo, and found that patients had improved outcomes on TV-46000 regardless of dosing schedule.
“Relapse rates among people living with schizophrenia are quite staggering, ranging between 50% and 92% globally. It is crucial to provide patients and prescribers with treatment options that have the potential to reduce relapse rates to help manage and stabilize the disease over time,” said Eran Harary, MD, VP global head of Specialty R&D at Teva, in a press release. “Coming off the heels of the recent FDA acceptance of our New Drug Application, we’re proud to be sharing our Phase 3 data at this year’s Psych Congress. We are committed to investigating the full potential of our subcutaneous long-acting injectable (LAI) formulation of risperidone for the treatment of this complex and burdensome illness.”
In the phase 3, randomized, double-blind, placebo-controlled RISE study, 544 patients with schizophrenia were randomized 1:1:1 to receive either TV-46000 q1m, TV-46000 q2m, or placebo. The primary endpoint of the study was time to impending relapse, with secondary endpoints including proportions of patients with impending relapse at week 24 and proportions of patients who maintained stability at week 24.
According to the investigators, TV-46000 showed significant benefits to the time to impending relapse compared to placebo. Further, TV-46000 prolonged time to relapse by 3.5 times overall, 5.0 times for the q1m group, and 2.7 times for the q2m group. The overall proportion of patients with impending relapse at week 24 was 9% across the 2 TV-46000 groups, compared to 28% in the placebo group.
“When managing schizophrenia, it is crucial to have treatment options that work to reduce the risk of relapse. As researchers, physicians and providers, we must work together to address this,” said John Kane, MD, professor and chairman, Department of Psychiatry, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and RISE lead investigator, in a press release. “These latest data from the Phase 3 RISE study are quite encouraging for both patients and providers.”
New phase 3 data presented at Psych Congress 2021 showed TV-46000/mdc-IRM significantly prolonged time to impending relapse compared to placebo in patients with schizophrenia [news release]. Teva; October 30, 2021. Accessed November 1, 2021. https://www.businesswire.com/news/home/20211030005002/en/New-Phase-3-Data-Presented-at-Psych-Congress-2021-Showed-TV-46000mdc-IRM-Significantly-Prolonged-Time-to-Impending-Relapse-Compared-to-Placebo-in-Patients-with-Schizophrenia