Reviva Pharmaceuticals Holdings, Inc. announced that 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. 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 the Q2-2024.