Business
Reviva Pharmaceuticals Announces Global Enrollment Update for Pivotal Phase 3 RECOVER Study Evaluating Brilaroxazine for Schizophrenia
- Enrollment ongoing at multiple sites in the US and Europe; site initiation in Asia expected in November 2022 - - Enrollment on pace, with over 30% enrolled
About this update from Reviva Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"- Enrollment ongoing at multiple sites in the US and Europe; site initiation in Asia expected in November 2022 - - Enrollment on pace, with over 30% enrolled in the United States - - Topline data for RECOVER evaluating brilaroxazine for schizophrenia expected in mid-2023 - CUPERTINO, Calif., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), cardiovascular, metabolic, and inflammatory diseases, today announced over 30% enrollment in the United States, and initiation and ongoing enrollment across sites in Europe for the pivotal Phase 3 RECOVER study evaluating brilaroxazine for the treatment of schizophrenia. The Company has received regulatory approval for initiating the study in Asia (India), with enrollment at multiple sites in India expected in 2022. “Our pivotal, global Phase 3 trial for our lead clinical candidate brilaroxazine continues to progress well, with over 30% enrolled in the United States, multiple sites recently initiated in Europe, and planned initiation of multiple sites in India before year-end,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO. “No treatment-related serious adverse events or major safety and tolerability concerns have been observed to date in this double-blind Phase 3 study. We remain highly encouraged by the potential for brilaroxazine to offer a safe, well-tolerated and efficacious treatment option for patients with schizophrenia which afflicts an estimated 24 million people worldwide. We remain on track to share topline Phase 3 data in mid-2023.” RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 15 mg or 50 mg once daily for 28 days. A 52-week open-label extension study with flexible doses of 15 mg, 30 mg, or 50 mg will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Since Reviva initiated its first clinical site at the end of January in the United States, the Company continues to ...