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Reviva Pharmaceuticals announced today that it has achieved positive results from a pivotal Phase 3 trial of its drug brilaroxazine, a serotonin-dopamine signaling modulator intended for adults with schizophrenia. The trial showed a statistically significant outcome, meeting the primary endpoint with the 50 mg dose.
The drug demonstrated a clinically meaningful 10.1-point reduction in the Positive and Negative Syndrome Scale score at week 4 versus placebo. This result was accompanied by significant reductions in all major symptom domains. Furthermore, the 15 mg dose surpassed placebo on most secondary endpoints, achieving significance on two key ones.
Looking ahead, Reviva Pharmaceuticals plans to commence another Phase 3 trial in Q1 2024. Long-term data from the current trial is expected to be released in Q4 2024. The company also has plans to submit a New Drug Application to the FDA in 2025.
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