Vistagen Therapeutics announces encouraging results from its Phase 2A clinical study of PH80, a neuroactive nasal spray designed for the acute management of premenstrual dysphoric disorder (PMDD). PMDD is a severe, sometimes disabling extension of premenstrual syndrome (PMS). PMDD symptoms can be extremely limiting to daily functioning and can cause extreme mood shifts that can disrupt daily life and damage relationships.

The exploratory Phase 2A study was randomized, double-blind, and placebo-controlled, involving 52 subjects with a history of PMDD. The study aimed to assess the efficacy, safety, and tolerability of PH80. Subjects were first administered a placebo nasal spray, and those showing no symptom improvement were eligible for the main part of the study. During their next menstrual cycle, participants were randomized to receive either PH80 or a placebo. The nasal spray was self-administered up to four times a day for six consecutive days prior to the estimated onset of menses.

Results from the study demonstrated that PH80 was both statistically and clinically significant in improving PMDD symptoms compared to a placebo. According to the Penn Daily Symptom Report (DSR), a subject-rated scale, significant improvements were observed as early as Day 4, continuing to Day 6. By Day 6, the change in baseline symptoms was -12.1 for the PH80 group versus -7.6 for the placebo group, indicating a meaningful improvement. The clinician-rated Premenstrual Tension Scale (PMTS) also revealed significant improvement in the PH80 group.

Safety was a crucial focus in this study. The data showed that PH80 was well-tolerated with no serious adverse events. The most commonly reported adverse event was a headache, which occurred in 17% of the placebo group and 7% of the PH80 group.

Interestingly, the analysis highlighted that mood symptoms seemed particularly responsive to PH80:

  • Depression: Reported by 0% in the PH80 group compared to 68% in the placebo group.
  • Irritability: Reported by less than 3% in the PH80 group versus 43% in the placebo group.
  • Anxiety: Reported by 0% in the PH80 group compared to 35% in the placebo group.
  • Difficulty Concentrating: Reported by 0% in the PH80 group and 18% in the placebo group.

“Symptoms of PMDD affect 5% to 8% of menarcheal individuals and there are limited effective treatment options that help with both physical and mood symptoms. The previously unreported results of this exploratory Phase 2A clinical study of PH80 signal a potential revolutionary method for treating premenstrual mood symptoms,” said Shawn Singh, Chief Executive Officer of Vistagen. “PMDD symptoms can be extremely limiting to daily functioning and PH80 demonstrated the potential to alleviate these symptoms. Interestingly, improvements in the mood items of depression and dysphoria were observed both by subject- and clinician-rated scales. Along with the previously reported efficacy of PH80 for the treatment of hot flashes due to menopause, PH80 efficacy in PMDD further supports its potential as a valuable and differentiated treatment option for multiple indications in women’s healthcare.”

This study builds upon Vistagen’s previous research that demonstrated the efficacy of PH80 in treating vasomotor symptoms like hot flashes due to menopause. The company believes PH80 could become a valuable and differentiated treatment option for multiple aspects of women’s health.

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