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Reviva Pharmaceuticals Announces Update on RECOVER, a Pivotal Phase 3 Global Study Evaluating Brilaroxazine for the Treatment of Schizophrenia
CUPERTINO, Calif., May 03, 2022 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage
About this update from Reviva Pharmaceuticals Holdings, Inc.
[{"type":"text","content":"CUPERTINO, Calif., May 03, 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 that the RECOVER study is progressing well and all sites in the United States (U.S.) have been initiated. Global sites in Europe and India remain on track to initiate in mid-2022. “We are extremely fortunate to have a team of industry experts with decades of clinical trial experience working in concert with our external CRO to ensure timelines remain on track for both the main 28 day once daily dose double-blind study in patients with acute schizophrenia as well as the 52-week open label extension study to further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO. “The Phase 3 RECOVER study continues to progress well, with brilaroxazine demonstrating a safe and well tolerated profile with no serious treatment related events to date. We look forward to sharing further updates on enrollment in the second half of 2022 and anticipate providing topline 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 will further evaluate the long-term safety and tolerability of brilaroxazine in patients with stable schizophrenia. Since Reviva initiated its first clinical site in Bentonville, Arkansas, led by principal investigator Dr. Fayz A. Hudefi, M.D. at the end of January, the team has initiated 15 geographically diverse sites across the United States. The ex-US sites in Europe and India remain on track to initiate in mid-2022. About RevivaReviva is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their familie...