Vistagen's Nasal Spray Shows Efficacy In Menopausal Hot Flashes

Vistagen Therapeutics Inc VTGN announced 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 (vasomotor symptoms) in women diagnosed with menopausal hot flashes.

PH80 was well-tolerated with no serious adverse events, and the adverse event profiles were comparable between PH80 and placebo. 

Also Read: Social Anxiety Disorder Impacts Around 23.7M People In US, Vistagen Releases Details Around Nasal Spray Treatment Program For It.

PH80 induced a significant reduction in the daily number of hot flashes compared to the 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. 

At baseline, subjects reported a mean daily number of hot flashes of 7.7 (PH80, n=18) and 8.0 (placebo, n=18). 

After one week of treatment, the number of hot flashes dropped to 2.8 (PH80) and 6.4 (placebo), and after four weeks of treatment, the number of hot flashes dropped to 1.5 (PH80) and 5.1 (placebo). 

PH80 treatment also significantly reduced the severity, disruption in function, and sweating related to hot flashes during the treatment period compared to the placebo.

Price Action: VTGN shares are down 9.91% at $2.69 on the last check Wednesday.