Vistagen gets FDA 'Study May Proceed' letter for refisolone nasal spray in menopausal hot flashes

Vistagen Therapeutics, Inc.

FDA allows Vistagen to pursue further Phase 2 clinical development of refisolone in U.S. for vasomotor symptoms due to menopause.
Exploratory Phase 2a study (N=36): refisolone reduced hot flash frequency by 80% vs 36% placebo; effect seen by week 1 (p<.001).
Refisolone was well-tolerated with no serious drug-related adverse events in the Phase 2a study conducted in Mexico.
Company cites large unmet need: ~75% of women in America experience hot flashes during menopausal transition.

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