Reviva announces enrollment update for OLE study of brilaroxazine

Reviva Pharmaceuticals (RVPH) announced an enrollment update to the ongoing 1-year open-label extension, OLE, study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. “We are pleased with the pace of enrollment of our OLE study which includes 108 patients that have completed 12 months of treatment and over 250 patients have completed 6 months of treatment. Importantly, we have collected long-term safety data in 100 patients with one year of treatment which is a requirement for our planned New Drug Application submission to the Food and Drug Administration (FDA),” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Brilaroxazine continues to be generally well tolerated across patients with acute and stable schizophrenia in the OLE study to date. We now expect to report topline 12-month long-term safety and efficacy data in December of 2024.”