Vistagen Therapeutics (NASDAQ: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (“CNS”) disorders, is reporting on study results for PH80, one of its five investigational neuroactive nasal sprays. According to the announcement, PH80 exhibited statistically significant improvement versus placebo in an exploratory phase 2A study for acute management of the symptoms of premenstrual dysphoric disorder (“PMDD”), including negative mood and physical and behavioral symptoms. The treatment was well tolerated, with side effects similar to a placebo. The company notes that this data reinforces information gathered from a previous study, which explored the efficacy, safety and tolerability of intranasal administration of PH80 for the acute management of PMDD.
“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,” said Vistagen CEO Shawn Singh in the press release. “The previously unreported results of this exploratory Phase 2A clinical study of PH80 signal a potential revolutionary method for treating premenstrual mood symptoms. 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.”
To view the full press release, visit https://ibn.fm/m3sI1
About Vistagen Therapeutics Inc.
Vistagen Therapeutics is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The company is advancing therapeutics with the potential to be faster acting and with fewer side effects and safety concerns than treatments that are currently available for treatment of anxiety, depression and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including fasedienol (“PH94B”), itruvone (“PH10”), PH15, PH80 and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug antagonist of the N-methyl-D-aspartate receptor (“NMDAR”). Pherines are neuroactive nasal sprays designed with an innovative proposed mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic uptake or direct activity on CNS neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression and several other CNS disorders. For more information about the company, please visit www.Vistagen.com.
NOTE TO INVESTORS: The latest news and updates relating to VTGN are available in the company’s newsroom at https://ibn.fm/VTGN
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