Reviva Announces FDA Alignment on Brilaroxazine Clinical Trials for NDA in Schizophrenia

- FDA acceptance of 4-week global registrational Phase 3 RECOVER-2 study -

- Two positive 4-week studies plus a 12-month long-term safety study have potential to support a New Drug Application (NDA) for brilaroxazine in schizophrenia –

- Topline data from 1-year open-label extension (OLE) long-term safety trial expected in Q4 2024 -

CUPERTINO, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, announced today 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. In addition, FDA indicated that it will require a long-term randomized withdrawal study post-approval to support maintenance of effect.

“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.”

RECOVER-2 is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter, 4-week study designed to assess the safety and efficacy of brilaroxazine in approximately 450 patients with acute schizophrenia compared to placebo. Brilaroxazine will be administered at fixed doses of 30 mg or 50 mg once daily for 28-days. The primary endpoint is a decrease in Positive and Negative Symptoms Assessment total score compared to placebo from baseline to Day 28. Key secondary endpoints include clinical global impression (CGI) severity, positive and negative symptoms, social functioning, and cognition, and key biomarkers implicated in neuroinflammation. Reviva plans to initiate the first clinical site in this quarter (Q2-2024).