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

Oct 30, 2021

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).

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