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
TEL AVIV, Israel & PARSIPPANY, N.J.: Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from the pivotal Phase 3 Risperidone Subcutaneous Extended-release (RISE) study comparing TV-46000/mdc-IRM once monthly (q1m) and TV-46000/mdc-IRM once every two months (q2m) with placebo (1:1:1) in patients with schizophrenia who underwent stabilization on oral risperidone. Results showed treatment with TV-46000 (overall, q1m or q2m) significantly prolonged time to relapse, decreased proportions of patients with impending relapse at week 24 and demonstrated significant increase in proportions maintaining stability. The safety profile of TV-46000, as demonstrated in this study, is consistent with other formulations of risperidone. The most common adverse reactions (≥5% and greater than placebo) were nasopharyngitis, increased weight, and extrapyramidal disorder. These findings, among others, were presented during the poster session at the 2021 Psych Congress Annual Meeting taking place Oct. 29-Nov. 1, 2021 in San Antonio, TX (in addition to virtual participation).
Schizophrenia is a chronic and severe mental disorder1 characterized by distortions in thinking, perception, emotions, language, sense of self and behavior.2 Twenty million people worldwide are affected by schizophrenia1, often living with considerable disability.2 Currently, about 70% of people living with schizophrenia are not receiving appropriate care3 despite the treatability of the illness.2
“Relapse rates among people living with schizophrenia are quite staggering, ranging between 50 and 92% globally.4,5 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. “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.”
“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. “These latest data from the Phase 3 RISE study are quite encouraging for both patients and providers.”
Efficacy and Safety of Subcutaneous Risperidone Injectable (TV-46000) in Patients With Schizophrenia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study (RISE Study)
The Phase 3 RISE study was designed to compare TV-46000 q1m and TV-46000 q2m with placebo (1:1:1 ratio; stage 2) in patients with schizophrenia who underwent stabilization on oral risperidone (stage 1). The primary endpoint was time to impending relapse and secondary endpoints included proportions of patients with impending relapse at week 24 and proportions of patients who maintained stability at week 24. No new safety signals were identified with TV-46000 versus accumulated safety data of oral risperidone and other long-acting risperidone formulations.
Out of 1267 patients screened, 863 were enrolled and 544 were randomized. Time to impending relapse significantly favored TV-46000 (hazard ratio [95% CI]; overall: 0.283 [0.184, 0.435], P<.0001; q1m: 0.200 [0.109, 0.367], P<.0001; q2m: 0.375 [0.227, 0.618], P<.0001) versus placebo. TV-46000 also prolonged time to relapse by 3.5, 5.0 and 2.7 times, respectively, versus placebo. Proportions of patients with impending relapse at week 24 were significantly lower for TV‑46000 (overall: 9%; q1m: 7%; q2m: 11%) versus placebo (28%; P<.0001, P<.0001, P=.0001, respectively). Proportions of patients maintaining stability were significantly higher (83%, 87%, 80% vs 61%; P<.0001, P<.0001, P=.0001, respectively). The safety profile of TV-46000, as observed in this study, is consistent with other formulations of risperidone. The most common adverse reactions (≥5% and greater than placebo) were nasopharyngitis, increased weight, and extrapyramidal disorder.
About TV46000-CNS-30072 (The RISE Study – The Risperidone Subcutaneous Extended-Release Study)
The RISE study was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of risperidone extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 13-65 years) with schizophrenia. 544 patients were randomized to receive a subcutaneous injection of TV-46000 once monthly (q1M), once every two months (q2M), or placebo in a 1:1:1 ratio. The primary endpoint was time to impending relapse.
