Vistagen Reports Favorable Safety and Efficacy Signals for Repeat-Dose Fasedienol in Social Anxiety Disorder

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โดย GlobeNewswire·US·Read original
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Vistagen announced topline results from an exploratory Phase 2 repeat-dose study of fasedienol nasal spray for the acute treatment of social anxiety disorder, demonstrating favorable safety and tolerability similar to single-dose administration. The three-arm, multicenter, randomized, double-blind, placebo-controlled study enrolled 61 adults and assessed two 3.2 µg doses given ten minutes apart versus a single 3.2 µg dose and placebo during a public speaking challenge. While the primary endpoint of change in subjective units of distress score did not reach statistical significance, both active arms showed numerical separation from placebo, with pooled fasedienol achieving a mean change of -15.0 compared to -6.8 for placebo. In a prespecified analysis of patients with very severe social anxiety disorder, defined by a baseline Liebowitz Social Anxiety Scale score of 95 or higher, single-dose fasedienol demonstrated nominally statistically significant improvement versus placebo, and the pooled fasedienol group also showed nominally significant results. Responder rates on secondary endpoints were directionally higher for fasedienol, with repeat-dose rates more than double those of placebo in the total population and four times or greater in the very severe subgroup. Vistagen plans to discuss these findings with the FDA regarding a potential registrational pathway for fasedienol.

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VistaGen Therapeutics Inc
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Favorable safety and efficacy signals in repeat-dose study, with nominally significant results in severe subgroup, supporting potential registrational pathway.

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