Reviva Pharmaceuticals Holdings announced today the successful completion of its pivotal Phase 3 trial evaluating the efficacy, safety, and tolerability of brilaroxazine in treating schizophrenia in adults. The trial yielded promising results, meeting its primary endpoint with a significant reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to the placebo.
Key Findings
At the 50 mg dose, brilaroxazine demonstrated a statistically significant and clinically meaningful 10.1-point reduction in PANSS total score at the four-week mark. This outcome highlights the potential of this serotonin-dopamine signaling modulator as an effective treatment option for schizophrenia.
Moreover, brilaroxazine exhibited statistically significant and clinically relevant improvements across all major symptom domains and secondary endpoints at the four-week mark compared to the placebo. Notably, the 15 mg dose of brilaroxazine also showed superiority to the placebo on the primary endpoint and several key secondary endpoints, reaching statistical significance.
Future Prospects
Looking ahead, Reviva Pharmaceuticals plans to release long-term data from this trial in the fourth quarter of 2024. Additionally, they aim to commence a Phase 3 trial in early 2024, with the goal of further supporting their New Drug Application submission to the FDA anticipated in 2025.
