Vistagen's PH80 neuroactive nasal spray demonstrated statistically significant efficacy versus placebo in an exploratory double-blind, placebo-controlled Phase 2A study in women diagnosed with menopausal hot flashes. Fuji will make a non-refundable payment of
'As we have seen across our neuroactive pherine nasal spray pipeline, PH80 offers exciting potential to transform a significant segment of a major healthcare market, including the current treatment landscape for women's healthcare,' said
'Our core mission at
About PH80
PH80 is a rapid-onset neuroactive pherine nasal spray product candidate designed to be used in a manner analogous to a rescue inhaler for asthma, taken by patients as-needed up to multiple times daily. Several pharmacokinetic and toxicokinetic studies show that PH80 administered intranasally is below the level of detection in plasma of human subjects and laboratory animals. Based on other studies conducted by Vistagen, pherine molecules have no detectable uptake in the brain and do not absorb systemically. All these data, along with the minimal adverse events reported in all clinical studies to date, demonstrate the excellent safety profile of this new class of molecules. In a placebo-controlled exploratory Phase 2A clinical trial, PH80 demonstrated an excellent safety profile and potential as a new treatment for moderate to severe vasomotor symptoms (hot flashes) associated with menopause.
About Vasomotor Symptoms (Hot Flashes) due to Menopause
Hot flashes are vasomotor symptoms (VMS) commonly experienced by women in menopause and are accompanied by hallmark symptoms such as sudden feelings of warmth, night sweats and flushed skin. Presentation of hot flashes is directly linked to changes in hormone levels due to menopause, or to menopause induced by other medical treatments or co-existing conditions, and the causal mechanism is unclear. Hot flashes are the most common symptom of the menopausal transition, affecting about 75% of menopausal women and about 40% of women in perimenopause. Current pharmacotherapies to treat hot flashes include hormonal therapy (estrogen with or without progesterone, or a synthetic progestin), gabapentins, certain antidepressants, clonidine and fezolinetant, a neurokinin 3 (NK3) receptor antagonist, all of which are associated with certain side effects.
About Exploratory Phase 2A Study of PH80 in Vasomotor Symptoms (Hot Flashes) due to Menopause
In a randomized, double-blind, placebo-controlled exploratory Phase 2A clinical study of PH80 (n=36) designed to explore the efficacy, safety and tolerability of intranasal administration of PH80 for the acute management of menopausal hot flashes in women, PH80 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
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