Premenstrual dysphoric disorder

• Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today announced that it will present posters detailing clinical trial data for fasedienol, an investigational pherine candidate in Phase 3 development for the acute treatment of social anxiety disorder (SAD), and PH80, a Phase 2 investigational pherine candidate for treatment of women’s health disorders, at the Anxiety and Depression Association of America (ADAA) Conference in Boston, Massachusetts from April 11 to 14, 2024.
• Title: PH80 Nasal Spray for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder: Results from a Phase 2a Study
  The posters will be available on the Publications page of Vistagen’s website on Monday, April 15, 2024.
• In addition to presenting fasedienol and PH80 clinical data, Vistagen will receive the ADAA 2024 Partner Recognition Award, recognizing Vistagen as a partner organization that has consistently contributed to the success of ADAA’s annual conference and supported ADAA’s public and professional mission.
• Vistagen and ADAA are committed to redefining the future of mental health care and bringing hope to millions of individuals affected by debilitating mental health disorders.

• When I ask my menstrual health workshop participants – including clinicians – there’s usually a lot of shrugging and shaking of heads.
• If given multiple choice options, most think that periods either “clean the womb” or somehow “help prepare for pregnancy”.
• Yes, the blood part can stain clothing, but there is nothing pathological, contaminating, or dangerous about periods.

So, why do we have periods?

• Periods likely evolved as a kind of preemptive abortion, to protect women from unviable or dangerous pregnancies.
• As a result, we have low rates of conception, high rates of miscarriage, and extremely high rates of maternal mortality in comparison to other mammals.
• The menstrual cycle is critical for facilitation of the initial steps of this raison d’être of the female reproductive system.
• The menstrual cycle is critical for facilitation of the initial steps of this raison d’être of the female reproductive system.

What else don’t we know?

• Perhaps with the fact that the second phase of the cycle from ovulation to menstruation is a series of highly inflammatory processes.
• This was only very briefly mentioned in three out of 16 textbooks.
• We really ought to be taught from puberty how to reduce period pain and blood loss – this is not difficult science.

Why aren’t we taught this stuff?

• My research shows that the exclusive focus on the female sex hormones in menstrual education is informed by societal influences, such as the myth of the hysterical or hormonal female.
• This gender myth is still alive and well, although now we tend to blame the (female sex) hormones.

• Again, there was no scientific reason for this change in focus, although it reflected existing societal beliefs about the inherently irrational behaviour of women.
• Unfortunately, menstrual health literacy has not yet recovered from this shift in physiological models.

So what?

• It also becomes much easier to differentiate premenstrual changes from underlying health conditions, since the latter will not be substantially alleviated by anti-inflammatory interventions alone.
• Teaching the reductive hormonal model of the menstrual cycle unintentionally provides pseudo-scientific evidence for the damaging hormonal or hysterical female gender myth.

Sally King is the founder of Menstrual Matters- the world's first evidence-based info hub on menstrual health and rights www.menstrual-matters.com. Her doctoral research and current research fellowship were funded by the ESRC (Economic and Social Research Council).

• Her latest project, the award-winning short film Hell Week, has captivated audiences and critics alike with its poignant exploration of Premenstrual Dysphoric Disorder (PMDD).
• The film has resonated deeply with viewers, sparking important conversations about mental health, women's experiences and the medical industry.
• The film's impact is undeniable, with Hell Week already selected for participation in eight prestigious film festivals, including the California Women's Film Festival and the London International Short Film Festival.
• Hell Week is directed by Kassandra Mahea, written by Mirejah Cruz and produced by Damon Cirulli and Mirejah Cruz.

• At the second study visit, subjects were randomized to receive a single dose of 0.9 µg PH80 nasal spray or placebo in the clinic.
• 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.
• Vistagen gained access to the results of the study in connection with its acquisition of Pherin in February 2023.