Reviva Pharmaceuticals announces Phase 3 RECOVER trial met primary endpoint

Reviva Pharmaceuticals announced positive topline results and successful completion of its pivotal Phase 3 RECOVER trial evaluating the efficacy, safety and tolerability of once-daily brilaroxazine, a serotonin-dopamine signaling modulator in adults with schizophrenia. The trial successfully met its primary endpoint, with brilaroxazine at the 50 mg dose achieving a statistically significant and clinically meaningful 10.1-point reduction in Positive and Negative Syndrome Scale total score compared to placebo at week 4. Brilaroxazine also achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs. placebo. The 15 mg dose of brilaroxazine was numerically superior to placebo on the primary endpoint and most secondary endpoints, and reached statistical significance on two key secondary endpoints. Key clinical safety and tolerability findings of brilaroxazine support a well-tolerated safety profile: No drug related serious adverse events or treatment-emergent SAEs observed or major safety concerns reported for brilaroxazine after 4 weeks of treatment; No incidence of suicidal ideation; No significant change in bodyweight, blood glucose levels, lipids levels, or endocrine hormones compared to placebo; Akathisia and extrapyramidal symptoms less than1% reported for brilaroxazine 50 mg and none for 15 mg; Low discontinuation rates with brilaroxazine that were less than placebo