Reviva Reports Positive Full Dataset For Phase 3 RECOVER OLE Study Of Brilaroxazine In Schizophrenia

(RTTNews) - Reviva Pharmaceuticals Holdings, Inc. (RVPH) Monday announced a positive full dataset following the completion of its Phase 3 RECOVER open-label extension (OLE) 1-year study evaluating the long-term safety, tolerability and efficacy of brilaroxazine in patients with schizophrenia. Results from the study showed that treatment with brilaroxazine led to strong broad-spectrum efficacy lasting more than 1 year and was generally well tolerated with a 35% discontinuation rate.

Long-term safety data from 100 patients who completed one year of treatment is required to submit NDA for brilaroxacin to the US Food and Drug Administration (FDA).