Reviva Pharmaceuticals announces FDA alignment on brilaroxazine trial

Reviva Pharmaceuticals Holdings announced it has gained alignment with the U.S. Food and Drug Administration, FDA, on its registrational Phase 3 program for brilaroxazine in schizophrenia. The FDA accepted a 4-week RECOVER-2 study for brilaroxazine in schizophrenia. Notably, 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. “We are pleased to receive positive feedback from the FDA and acceptance of a 4-week registrational study for our brilaroxazine program,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “The FDA also clarified that our NDA submission could include two 4-week phase 3 studies showing efficacy and a 12-month long-term safety study. Importantly, 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.”