Vistagen to Present Positive Fasedienol Phase 3 Data and Positive PH80 Phase 2A Data at Upcoming Scientific Conferences
Positive top-line results from fasedienol (PH94B) Phase 3 PALISADE-2 trial in social anxiety disorder (SAD) to be presented by SAD expert, Dr.
Positive results from PH80 Phase 2A study in women diagnosed with vasomotor symptoms (hot flashes) due to menopause to be presented at the 2023
“Vistagen’s presentations highlight the significant progress we have made to advance new therapies to address urgent unmet patient needs,” said
Key highlights of the oral and poster presentations include:
- Fasedienol data demonstrating statistically significant rapid-onset reduction in patient-reported Subjective Units of Distress Scale (SUDS) score compared to placebo in a public speaking challenge (primary endpoint, p=0.015) in adults diagnosed with social anxiety disorder (SAD).
- Fasedienol data demonstrating long-term, open-label treatment from nearly 500 patients was safe and well-tolerated and provided improved overall symptom control in adults with SAD.
- PH80 data demonstrating statistically significant reduction in the number of hot flashes compared to placebo (p<.001) after four weeks of treatment in women diagnosed with vasomotor symptoms (hot flashes) due to menopause.
CNS Summit 2023
Session: Neuroscience Spotlight
Topic: Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray for the Acute Treatment of Social Anxiety Disorder
Title: Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder
Poster Number: 109
Title: A Phase 2A Clinical Study to Investigate the Efficacy, Safety, and Tolerability of PH80 for the Acute Management of Menopausal Vasomotor Symptoms (Hot Flashes) in Women
Poster Number: 47
Title: A Phase 3 Open-label Safety Trial of Fasedienol (PH94B) Nasal Spray in the Treatment of Anxiety in Adults with Social Anxiety Disorder (SAD)
Presenter: Brittany Reed, PA
Poster Number: 89
Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns, than those currently available for the treatment of anxiety, depression, and multiple CNS disorders. Vistagen's pipeline contains six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH80, PH15, 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 of an antagonist of the N-methyl-D-aspartate receptor (NMDAR). Pherines are neuroactive nasal sprays designed with an innovative and differentiated proposed mechanism of action (MOA) that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic absorption or direct activity on 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. Connect at www.Vistagen.com.
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