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Tuesday, 08/08/2023 7:03:40 PM

Tuesday, August 08, 2023 7:03:40 PM

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Vistagen Announces Positive Top-Line Results from Phase 3

PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social

Anxiety Disorder



First positive U.S. Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years



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)



Trial also met the secondary endpoint, demonstrating a statistically significant reduction in proportion of responders compared to placebo as measured by the Clinical Global Impressions Improvement (CGI-I) scale (secondary endpoint, p=0.033)



Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials of fasedienol in social anxiety disorder



Over 25 million Americans are living with social anxiety disorder1
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