Reviva Announces Positive Phase 3 Results For Brilaroxazine In Schizophrenia

Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing treatments for the central nervous system (CNS), inflammatory, and cardiometabolic diseases. The firm has announced promising preliminary topline results from the open-label extension (OLE) of its ongoing Phase 3 RECOVER study. The study evaluates the long-term safety and efficacy of brilaroxazine in patients with schizophrenia. 

Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, said in the statement,  “We believe these topline preliminary long-term data build on the strong clinical evidence demonstrating that brilaroxazine can improve all major symptom domains of schizophrenia, and now importantly, show sustained efficacy over time. Moreover, the generally well-tolerated safety profile and high compliance rate following one year of treatment highlight the potential once daily brilaroxazine holds to address major barriers to successful long-term treatment in schizophrenia. 

He also commented,  “We look forward to reporting the full data set from the OLE portion of the RECOVER study, which will include long-term safety, tolerability and efficacy data, as well as vocal and blood biomarker data as additional independent measures of efficacy, expected in the first quarter of 2025.”

Once-daily administration of brilaroxazine showed positive and strong broad-spectrum efficacy sustained over a one-year period. The treatment was generally well-tolerated, with no single side effect exceeding 5%, and showed favourable patient adherence and a 35% discontinuation rate in the OLE phase. All three tested doses, 15 mg, 30 mg, and 50 mg, were effective and well-tolerated. The 52-week OLE phase builds on the positive findings from the initial double-blind, 4-week portion of the RECOVER study, reinforcing brilaroxazine’s long-term safety, efficacy, and treatment adherence profile.

Dr. Scott Bartley, MD, Chief Medical Officer and Principal Investigator for Pillar Clinical Research and Investigator in the RECOVER trials, mentioned,  “No current therapy addresses all needs of patients with schizophrenia. The broad-spectrum improvements in all major symptom domains, including negative symptoms, along with the low treatment discontinuation rates with long-term use of brilaroxazine are encouraging and support the potential of brilaroxazine to reduce the current burden on people affected by this debilitating and life-long mental illness.”

The OLE phase is being conducted across multiple global centres and assesses flexible dosing of 15, 30, or 50 mg of brilaroxazine once daily in patients with stable schizophrenia. Participants include those who completed the double-blind phase of RECOVER as well as new patients with stable schizophrenia. Long-term safety data for at least 100 patients who complete one year of treatment will be crucial for Reviva’s New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).