PH80 is an early-stage investigational synthetic neuroactive steroid with potential to engage receptors in nasal chemosensory cells that are neurally connected to the hypothalamus and limbic amygdala neural centers associated with the control of normal body temperature and pain.

Acute Management of Menopausal Hot Flashes

Hot flashes are a rapid and exaggerated heat dissipation response, consisting of sweating, peripheral vasodilation inducing reddening of the face and upper thorax, rapid heartbeat and feelings of internal heat and discomfort that can impact quality of life.

Hot flashes are triggered by small elevations in core body temperature acting within a greatly reduced thermoneutral zone (region between the upper [sweating] and lower [shivering] thresholds). This is due in part, but not entirely, to estrogen depletion during menopause. Elevated central sympathetic activation, mediated through α2-adrenergic receptors, is responsible for narrowing of the thermoneutral zone.

In an exploratory double-blind, placebo-controlled Phase 2A study in women diagnosed with menopausal hot flashes (n=40) conducted at Hospital Angeles, Mexico City Mexico, treatment with PH80 showed clinically and statistically significant improvement in the number and severity of hot flashes and other symptoms of menopause in the subjects treated with PH80 as compared to placebo. Adverse events were mild and similar to placebo.

Acute Management of Menopausal Headaches

A migraine is characterized by unilateral, pulsating headaches of moderate to severe intensity lasting four to 72 hours. Symptoms are aggravated by routine physical activity and are associated with nausea, photophobia and phonophobia. Usually, migraine headaches are preceded by premonitory symptoms (fatigue neck discomfort, gastrointestinal symptoms and mood changes), and these are followed by an aura of sensory and language disturbance.¹

In an exploratory Phase 2A clinical study conducted at Hospital Angeles, Mexico City, Mexico, PH80 showed a profile compatible with the relief of the premonitory and aura symptoms of migraines.

1. Headache, 58: 4-16, 2018. American Headache Society