Reviva Announces Full Details of Positive Phase 2 Clinical Trial Results for Acute Schizophrenia
- Met endpoints for safety and efficacy in 234 patients’ clinical trial with Acute Schizophrenia or Schizoaffective Disorder
- Met primary endpoint of reduction in Positive and Negative Syndrome Scale (PANSS) total score for Schizophrenia
- Mitigated positive symptoms and negative symptoms
- Improved social functioning and cognition.
- No metabolic (weight gain, elevated blood sugar, increase in lipids), no endocrine (hypothyroidism, hyperprolactinemia) side effects and no increase in suicidal ideation compared to placebo.
Brilaroxazine has a unique pharmacology profile against key serotonin (5-HT) and dopamine (D) receptors, which
In its randomized, double-blind, placebo-controlled, multicenter Phase 2 trial to assess the safety and efficacy of brilaroxazine in 234 subjects with acute exacerbation of schizophrenia or schizoaffective disorder, brilaroxazine met its primary endpoint, which was reduction in total Positive and Negative Syndrome Scale (PANSS) at the end of the treatment from baseline versus placebo. The drug candidate also met all safety endpoints including clinical, labs, body weight, prolactin, lipids, fasting glucose, and EKG. The PANSS total score was reduced by 20 points, a statistically significant treatment difference from the placebo. Brilaroxazine also mitigated positive symptoms and negative symptoms, and improved social functioning and cognition. Importantly, the FDA has agreed to consider a potential ‘Superior Safety’ label claim, if there is a positive outcome on a relevant endpoint in a pivotal Phase 3 clinical study in schizophrenia.
Chief Executive Officer,
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Source: Reviva Pharmaceuticals