Reviva Announces FDA Alignment on Brilaroxazine Clinical Trials for NDA in Schizophrenia - Seite 2

About Schizophrenia
Schizophrenia is a complex and debilitating neuropsychiatric disorder that affects ~1% of the world’s population, and approximately 3.5 million people in the United States alone and 20 million globally. Characterized by multiple symptoms, patients with schizophrenia often suffer from cognitive impairment, delusions, hallucinations and disorganized speech or behavior. Despite its high prevalence, there are no therapies that adequately address the complex mix of positive and negative symptoms, mood, and cognitive impairment associated with schizophrenia. Limitations of current treatments include suboptimal efficacy, poor tolerability, and low patient adherence rates.

About Brilaroxazine
Brilaroxazine is an in-house discovered new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors implicated in schizophrenia and its comorbid symptoms. Positive topline data from the global Phase 3 RECOVER-1 trial in schizophrenia demonstrated the trial successfully met all primary and secondary endpoints with statistically significant and clinically meaningful reductions across all major symptom domains at week 4 with 50 mg of brilaroxazine vs. placebo with a generally well-tolerated side effect profile comparable to placebo and discontinuation rates lower than placebo. Positive data from a clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects supports no clinically significant interaction when combined with a CYP3A4 inhibitor. Reviva believes that a full battery of regulatory compliant toxicology and safety pharmacology studies has been completed for brilaroxazine. Reviva intends to develop brilaroxazine for other neuropsychiatric indications including bipolar disorder, major depressive disorder (MDD) and attention-deficit/hyperactivity disorder (ADHD).

Additionally, brilaroxazine has shown promising nonclinical activity for inflammatory diseases psoriasis, pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF) with mitigation of fibrosis and inflammation in translational animal models. Brilaroxazine has already received Orphan Drug Designation by the U.S. FDA for the treatment of PAH and IPF conditions. To learn more about the clinical and preclinical data available for brilaroxazine, please visit revivapharma.com/publications.