Vistagen (NASDAQ:VTGN) reported that PH80, one of the company’s five investigational neuroactive nasal sprays, demonstrated statistically significant efficacy versus placebo in an exploratory Phase 2A study for the acute treatment of hot flashes in women diagnosed with menopausal hot flashes.
The randomized, double-blind, placebo-controlled exploratory Phase 2A clinical study of PH80 was designed to explore the efficacy, safety, and tolerability of intranasal administration of PH80. All 36 subjects completed four weeks of treatment and no subject discontinued participation in the study as a result of adverse events.
PH80 induced significant reduction in the daily number of hot flashes, compared with placebo, at the end of the first week of treatment, and the improvement was maintained through each treatment week until the end of the treatment period.
PH80 treatment also significantly reduced the severity, disruption in function, and sweating related to hot flashes during the treatment period, compared with placebo.
In a statement, Shawn Singh, CEO of Vistagen, said the exploratory Phase 2A clinical study of PH80 for treatment of menopausal hot flashes is yet another part of the “promising larger body of evidence regarding the potential of our innovative pherine nasal spray pipeline.”
