Benzinga | Jan 10, 2022 06:09AM EST

Reviva Pharmaceuticals Holdings, Inc. Receives FDA May Proceed Letter For Pivotal Phase 3 Clinical Trial And Long-Term Safety Trial Evaluating Brilaroxazine For The Treatment Of Schizophrenia

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), cardiovascular, metabolic, and inflammatory diseases, announced today the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with Phase 3 clinical investigation of its lead candidate, brilaroxazine, a novel serotonin and dopamine receptor modulator for the treatment of schizophrenia.

"We believe that FDA clearance to proceed with initiation of a pivotal Phase 3 trial, as well as an additional Phase 3 trial focused on long-term safety, represents a transformative milestone that may support the filing and approval of a new drug application for our lead candidate brilaroxazine in patients with schizophrenia. Both Phase 3 trials will be initiated simultaneously, with the long-term safety study designed to supplement efficacy and safety data from the pivotal trial," said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. "Collectively these two trials may provide a robust Phase 3 assessment of brilaroxazine in patients with schizophrenia that we believe will complement our successful Phase 2 study. We remain highly encouraged by the therapeutic potential of brilaroxazine and look forward to initiating both Phase 3 trials by the end of January 2022."

Schizophrenia is a complex and debilitating neuropsychiatric disorder that affects ~1% of the world's population, and approximately 3.5 million people in the United States alone. Characterized by multiple symptoms, patients with schizophrenia often suffer from cognitive impairment, delusions, hallucinations and disorganized speech or behavior. Despite its high prevalence, there are no therapies that adequately address the complex mix of positive and negative symptoms, mood, and cognitive impairment associated with schizophrenia. Limitations of current treatments include suboptimal efficacy, poor tolerability and low patient adherence rates.