Vistagen Presents Fasedienol (PH94B) Safety and Exploratory Efficacy Data from Phase 3 Open-Label Social Anxiety Disorder Study at American Society for Clinical Psychopharmacology Annual Meeting

Favorable long-term, open-label treatment data from nearly 500 patients in real-world setting suggest that patient-tailored, as-needed administrations of fasedienol over time were safe and well-tolerated

Positive exploratory fasedienol efficacy data measured by the Liebowitz Social Anxiety Scale (LSAS) demonstrated clinically meaningful reductions in fear, anxiety and avoidance of anxiety-provoking social and performance situations in daily life, building on LSAS data from a previous real-world, placebo-controlled Phase 2 study of fasedienol in social anxiety disorder

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Vistagen (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, today announced that positive safety and exploratory efficacy data from its large Phase 3 open-label study of fasedienol (PH94B) nasal spray for the treatment of anxiety in adults with social anxiety disorder (SAD) were presented in a late-breaking poster presentation at the American Society for Clinical Psychopharmacology (ASCP) 2023 Annual Meeting taking place in Miami from May 30 through June 2, 2023.

The study was conducted in a real-world setting and was designed to evaluate the long-term safety and tolerability of multiple, patient-tailored, as-needed administrations of fasedienol in adults with SAD when they experienced social and performance stressors in their daily lives.

Safety

Long-term administration of 3.2 µg of fasedienol, as-needed up to four times per day, was safe and well-tolerated, with no new safety findings or trends identified, regardless of the number of doses administered by each subject (safety population: n=481), as previously reported. Headache was the most common treatment-emergent adverse event (TEAE) (17.0%); no other TEAE occurred in more than 5.0% of subjects, except for COVID-19 TEAEs (11.4%), which were not considered related to fasedienol. Over 30,000 doses of fasedienol were administered by patients during the study.

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