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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
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nFirst positive U.S. Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years\n\n\nStatistically 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)\n\n\nTrial 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)\n\n\nFasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials of fasedienol in social anxiety disorder\n\n\nOver 25 million Americans are living with social anxiety disorder1\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVistagen (NASDAQ: VTGN), a 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 positive top-line results from its Phase 3 PALISADE-2 trial evaluating the efficacy, safety, and tolerability of fasedienol (PH94B) nasal spray in adults diagnosed with social anxiety disorder (SAD). The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015). The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale (p=0.033). Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials.\n\n\n“We are thrilled that these compelling top-line results from the Phase 3 PALISADE-2 trial confirm what was seen in the Phase 2 studies in social anxiety disorder and highlight the potential for fasedienol, with its novel and unique proposed mechanism of action, to transform what is possible for more than 25 million people living with social anxiety in the U.S. and millions more affected worldwide,” stated Shawn Singh, Chief Executive Officer of Vistagen. “As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape ac...