- Reviva Pharmaceuticals Holdings Inc (NASDAQ:RVPH) has announced data from its clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects.
- The CYP3A4 enzyme is pivotal in helping the body metabolize and remove small foreign molecules and is primarily found in the liver and intestine.
- Brilaroxazine is a serotonin/dopamine modulator in late-stage clinical development for schizophrenia.
- A CYP3A4 inhibitor, itraconazole, slightly increased brilaroxazine Cmax, AUClast, and AUCinf by 6, 16 and 13%, respectively, in healthy volunteers (N=11).
- Similarly, a CYP3A4 inducer, phenytoin, in healthy volunteers (N=16) decreased brilaroxazine Cmax, AUClast, and AUCinf by 33, 56, and 53%, respectively.
- Brilaroxazine’s DDI study found no clinically significant interaction when combined with a CYP3A4 inhibitor.
- Brilaroxazine is currently being evaluated in RECOVER Phase 3 trial 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.
- Price Action: RVPH shares are up 2.72% at $4.15 during the premarket session on the last check Thursday.
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