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Vistagen Announces Positive Results from Exploratory Phase 2A Study of PH80 in Women Diagnosed with Menopausal Hot Flashes
PH80 nasal spray demonstrates statistically significant efficacy versus placebo in exploratory double-blind, placebo-controlled Phase 2A study (n=36) in
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nPH80 nasal spray demonstrates statistically significant efficacy versus placebo in exploratory double-blind, placebo-controlled Phase 2A study (n=36) in women diagnosed with menopausal hot flashes\n\n\nPH80 was safe and well-tolerated with an adverse event profile similar to placebo\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today 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.\n\n\nThe 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 for the acute management of menopausal hot flashes in women. In the study, PH80 nasal spray containing epoxyestrenolone 0.8 micrograms/50 microliters (0.8 µg/50 µL) was self-administered by subjects intranasally, two sprays in each nostril (total dose = 3.2µg) up to four times daily, as-needed for four consecutive weeks. One additional dose was allowed at night if subjects were awakened by hot flashes. Through the course of the study, subjects recorded the number, severity, disruption in function, and sweating related to hot flashes. PH80 was well-tolerated with no serious adverse events, and the adverse event profiles were comparable between PH80 and placebo. All 36 subjects completed four weeks of treatment and no subject discontinued participation in the study as a result of adverse events.\n\n\nPH80 induced significant reduction in the daily number of hot flashes compared to 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) (p","length":2715,"tagName":"div"}]