Reviva Pharmaceuticals’ Phase 3 Schizophrenia Program Receives FDA Acceptance
Reviva Pharmaceuticals (Nasdaq: RVPH) has received acceptance from the FDA for its 4-week registrational Phase 3 program for brilaroxazine in schizophrenia. Reviva’s RECOVER-2 study is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter, 4-week trial designed to assess the safety and efficacy of brilaroxazine in approximately 450 patients with acute schizophrenia compared to placebo.
The FDA also indicated that two positive Phase 3 studies showing efficacy at week 4 that are accompanied by long-term safety data of at least 12 months could be supportive of an NDA submission for the acute treatment of schizophrenia.
Commenting on the news, Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, said, “We have already successfully completed and announced the results of our pivotal Phase 3 RECOVER trial in October 2023, and we are set to initiate our RECOVER-2 trial during this quarter. We expect topline data from our 1-year OLE trial in the fourth quarter of this year. Collectively, we expect to have completed all of the outlined NDA submission requirements by the third quarter of 2025.”
Reviva said that the FDA has indicated that it will require a long-term randomized withdrawal study post-approval to support maintenance of effect.
Schizophrenia is a complex and debilitating neuropsychiatric disorder that affects ~1% of the world’s population, and approximately 3.5 million people in the United States alone and 20 million globally.
About Reviva
Reviva is a late-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 families. Reviva’s current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva’s pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.
