Vistagen announced that a Phase 2a trial of the company’s PH80 intranasal epoxyestrenolone in menopausal women experiencing hot flashes demonstrated statistically significant reduction in the frequency and severity of the hot flashes. The company acquired PH80 when it acquired Pherin Pharmaceuticals earlier this year and the Phase 2a trial was conducted by Pherin at some point prior to the acquisition.
According to Vistagen, the Phase 2a trial enrolled 36 women and compared a 3.2µg dose of PH80 used up to 4 times daily, as needed, for 4 weeks. The company said that the nasal spray was well tolerated with no serious adverse events, and the mean daily number of hot flashes was reduced from 7.7 to 2.8 in the PH80 group after one week compared to a reduction from 8 to 6.4 in the placebo group. After 4 weeks, the number of daily hot flashes was reduced to 1.5 in the PH80 group compared to 5.1 in the placebo group.
Vistagen recently received a patent covering the use of PH80 nasal spray for treatment of migraines. In addition to PH80, the company is developing several other Pherin nasal sprays, and initiated a Phase 1 trial of PH10 nasal spray, which the company is developing for the treatment of major depressive disorder, earlier this year. Vistagen also recently announced Phase 3 results for its fasedienol (PH94B, aloradine) nasal spray for the treatment of social anxiety.
Vistagen CEO Shawn Singh commented, “The previously unreported results of this exploratory Phase 2A clinical study of PH80 for treatment of menopausal hot flashes are yet another part of the promising larger body of evidence regarding the potential of our innovative pherine nasal spray pipeline. There is clearly a need for an alternative treatment option for menopausal hot flashes that provides rapid relief without the safety, side effects, and treatment burden of the currently available options. We are encouraged by the potential that PH80 holds to improve the treatment paradigm for hot flashes and reduce the serious physical burden on the quality of life experienced by millions of women worldwide.”
Read the Vistagen press release.
