- Reviva Pharmaceuticals Holdings Inc RVPH Has announced dates from its drug-drug interaction (DDI) clinical study examining the potential effect of the CYP3A4 enzyme on brilaroxazine in healthy subjects.
- The CYP3A4 enzyme is critical for the body to metabolize and remove small foreign molecules and is found primarily in the liver and intestines.
- 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 subjects (N=11).
- Similarly, in healthy volunteers (N=16), a CYP3A4 inducer, phenytoin, decreased brilaroxazine Cmax, AUClast, and AUCinf by 33, 56, and 53%, respectively.
- The DDI study of brilaroxazine did not reveal a clinically significant interaction when combined with a CYP3A4 inhibitor.
- Brilaroxazine is currently being evaluated in the phase 3 RECOVER study to evaluate the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo.
- Topline data is expected in mid-2023.
- Price promotion: RVPH shares are up 2.72% to $4.15 during the premarket session last check Thursday.
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