Investigational nasal spray shows promise vasomotor symptom treatment

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A new study evaluating PH80 (epoxyestrenolone; Vistagen), an investigational non-hormonal nasal spray, has shown significant promise in reducing vasomotor symptoms (VMS), including hot flashes, in menopausal women, according to a poster presented at the 2024 Annual Meeting of The Menopause Society in Chicago, Illinois.

PH80, also known as epoxyestrenolone, works by activating olfactory-limbic-hypothalamic neural circuits through nasal chemosensory receptors, which regulate the sympathetic nervous system's activity in cutaneous vasculature and sweat glands.

The randomized, placebo-controlled, double-blind study followed 36 women with moderate-to-severe VMS over 4 weeks.

Study participants self-administered up to 5 daily doses of either placebo or PH80, as needed.

At the start of the trial, patients experienced an average of 8 or more hot flashes per day. After just 1 week of treatment, the number of hot flashes in those using PH80 dropped to an average of 3 per day, compared to 6 per day in the placebo group.

By the end of the 4-week study, the PH80 group reported just 1.5 hot flashes per day, while the placebo group averaged five.

Additionally, PH80 significantly reduced the severity of symptoms, disruption to daily life, and sweating in the treatment group.

Both patient-reported (PGI-C) and investigator-reported (CGI-I) improvements in symptoms were higher in those using PH80 compared to placebo, with statistical significance reached in patient reports (P = 0.015) and near significance in investigator reports (P = 0.053).

Safety was also evaluated in the study, and PH80 was found to be as well-tolerated as the placebo, with no significant side effects reported.

This study highlights PH80 as a promising new option for women seeking relief from menopausal hot flashes, offering an effective, non-hormonal alternative to traditional treatments.

PH80 Nasal Spray for Treatment of Vasomotor Symptoms (Hot Flashes)

Reference:

Monti L, Baker RA, Salmon A, Hanover R. Associated with Menopause: a Phase 2 Randomized, Controlled Study. Poster presentation. Presented at: The 2024 Annual Meeting of The Menopause Society. Chicago, Illinois. September 10-14, 2024.