Reviva Pharma Announces Positive Data From DDI Study Of CYP3A4 Enzyme Effect On Brilaroxazine
(RTTNews) - Biopharmaceutical company Reviva Pharmaceuticals Holdings, Inc. (RVPH) announced Thursday positive data from its recently completed clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects.
The CYP3A4 enzyme plays a pivotal role in helping the body metabolize and remove small foreign molecules and is primarily found in the liver and intestine.
DDI evaluation is a critical clinical pharmacology study required by the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally for approving a new drug to market.
Brilaroxazine is a serotonin/dopamine modulator in late-stage clinical development for the treatment of schizophrenia.
Following FDA guidelines, the DDI clinical study was designed to evaluate the drug interaction effect of a strong CYP3A4 inhibitor or inducer when co-administered with brilaroxazine in healthy volunteers.
Reviva believes that brilaroxazine's clinical safety is further reinforced with the positive results of this DDI study, which found no clinically significant interaction when combined with a CYP3A4 inhibitor.
Brilaroxazine is currently being evaluated in RECOVER, a pivotal global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. Topline data is expected in mid-2023.
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