Vistagen, a late-stage clinical biopharmaceutical company focused on neuroscience and developing intranasal therapies called pherines, announced that the final patient has completed the randomized, double-blind, placebo-controlled portion of the PALISADE-3 Phase 3 trial evaluating fasedienol for the acute treatment of social anxiety disorder. The study’s open-label extension is ongoing, allowing participants to continue using fasedienol under supervision.

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Shawn Singh, President and Chief Executive Officer, said, “Completing the PALISADE-3 Phase 3 public speaking challenge study is a major milestone for Vistagen. As we look forward to topline results later this quarter, we are encouraged by the potential of fasedienol to become the first acute treatment for the more than 30 million people living with social anxiety disorder. We sincerely thank the study participants, clinical investigators, site staff, and our contract research organization for their dedication and collaboration.”

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Earlier, in August 2023, Vistagen reported positive outcomes from the PALISADE-2 Phase 3 trial, which shared the same public speaking challenge study design and primary endpoint as PALISADE-3 and the ongoing PALISADE-4 trial, while incorporating improvements in site training and subject selection. Both PALISADE-3 and PALISADE-4 assess the efficacy and safety of a single dose of fasedienol in reducing anxiety during a simulated public speaking challenge, with the Subjective Units of Distress Scale as the primary measure. Participants in the PALISADE-3 open-label extension may continue fasedienol treatment for up to twelve months. The FDA has granted Fast Track designation to fasedienol for the acute treatment of social anxiety disorder, and the company believes that positive results from these trials could support a New Drug Application submission.

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