USFDAApr 28, 2026, 04:18 PM
VTGN Refisolone Nasal Spray Gets FDA 'Study May Proceed' for Phase 2
AI Summary
Vistagen Therapeutics, Inc. announced it received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for refisolone nasal spray. This non-hormonal, non-systemic product candidate is in Phase 2 development for treating moderate to severe vasomotor symptoms (hot flashes) due to menopause. The FDA's decision allows Vistagen to advance refisolone into further Phase 2 clinical development in the U.S., building on successful exploratory Phase 2a studies conducted in Mexico.
Key Highlights
- Vistagen received a "Study May Proceed" letter from the FDA for refisolone nasal spray.
- The letter enables further U.S. Phase 2 clinical development for vasomotor symptoms (hot flashes).
- Refisolone is a non-hormonal, non-systemic product candidate for menopause-related hot flashes.
- Exploratory Phase 2a study in Mexico showed 80% hot flash frequency reduction vs. 36% for placebo.
- Reduction in hot flash frequency was observed as early as one week (p < .001).
- Refisolone was well-tolerated in the study with no serious drug-related adverse events.
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