Vistagen Receives FDA “Study May Proceed” Letter Under its Refisolone IND Application, Enabling Further Phase 2 Clinical Development for the Treatment of Vasomotor Symptoms (Hot Flashes) due to Menopause
Vistagen received a 'Study May Proceed' letter from the FDA for its Refisolone IND application, clearing the way for further Phase 2 clinical development in the U.S. for menopausal vasomotor symptoms. The regulatory decision builds on exploratory Phase 2a data where Refisolone demonstrated an 80% reduction in hot flash frequency compared to 36% for placebo, with no serious adverse events.
Key figures
- Drug Name
- Refisolone (PH80)
- Phase Of Trial
- Phase 2
- Dose micrograms
- 3.2
- Phase 2a sample size
- 36
- Hot flash reduction placebo
- 36%
- Hot flash reduction treatment
- 80%
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