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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
Brilaroxazine is a serotonin\/dopamine modulator in late-stage clinical development for the treatment of schizophrenia.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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.<\/p>\n
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