PH80 is an odorless, tasteless synthetic investigational pherine with a novel, rapid-onset proposed mechanism of action (MOA) with potential to treat multiple women’s health disorders. PH80’s proposed MOA is fundamentally differentiated from the MOA of all currently approved treatments for vasomotor symptoms (hot flashes) due to menopause and premenstrual dysphoric disorder (PMDD), and other women’s health disorders. Administered as a nasal spray at microgram-level doses, PH80 activates chemosensory neurons in the nasal cavity connected to neural circuits in the brain that modulate the basal forebrain.

A Differentiated Approach to Management of Vasomotor Symptoms (Hot Flashes) due to Menopause

Approximately 60% to 80% of women entering menopause suffer from hot flashes and associated symptoms lasting up to ten years, according to the Massachusetts General Hospital Center for Women’s Mental Health.¹ Menopausal symptoms are triggered by hormonal fluctuations that develop at the onset of menopause and affect areas of the brain involved in the control of core body temperature. Sudden changes in core body temperature result in hot flashes, sweating, reddening of the face and upper thorax, rapid heartbeat, and general feelings of discomfort that can have an impact on the quality of life.

Based on Phase 2A clinical data demonstrating significant reduction in the daily number of menopausal hot flashes, as well as reduction in the severity, disruption in function, and sweating related to hot flashes during the treatment period, Vistagen believes PH80 has the potential to be a major advancement in the therapeutic treatment of hot flashes.

Vistagen is currently preparing to submit a U.S. IND for Phase 2B clinical development of PH80 for the treatment of patients with moderate to severe vasomotor symptoms (hot flashes) due to menopause.

Novel Acute Management of the Symptoms of Premenstrual Dysphoric Disorder

Premenstrual dysphoric disorder is a severe, sometimes disabling extension of premenstrual syndrome (PMS). Approximately, 5% to 8% of menarcheal individuals have moderate-to-severe symptoms that can cause significant distress and functional impairment, suggestive of PMDD². PMDD symptoms usually begin in the luteal phase (approximately seven to 10 days before a person’s period starts) and continue for the first few days of the period. Like PMS, PMDD can cause bloating, breast tenderness, fatigue, and changes in sleep and eating habits, but distinctively, it can also cause extreme mood shifts that can disrupt daily life and damage relationships. The cause of PMDD is not clearly understood, but it is thought that neurotransmitter systems may trigger PMDD. Brain areas that regulate emotion and behavior are studded with receptors for estrogen, progesterone, and other sex hormones. These hormones affect the functioning of neurotransmitter systems that influence mood and thinking, possibly triggering PMDD.

Based on Phase 2A clinical data demonstrating statistically and clinically significant improvement versus placebo in symptoms of PMDD, Vistagen believes PH80 has the potential to be a major advancement in the therapeutic management of symptoms of PMDD, including negative mood and physical and behavioral symptoms.

For more information on partnering with Vistagen, please contact us at bd@vistagen.com.

^{1. Massachusetts General Hospital Center for Women’s Mental Health, https://womensmentalhealth.org/posts/the-immense-burden-of-menopausal-symptoms/.}

^{2. Mishra S, Elliott H, Marwaha R. Premenstrual Dysphoric Disorder. [Updated 2023 Feb 19]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan.}