Social Anxiety Disorder Impacts Around 23.7M People In US, Vistagen Releases Details Around Nasal Spray Treatment Program For It

Vistagen Inc VTGN announced FDA feedback regarding using the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint for future clinical studies designed to evaluate the efficacy of a treatment for the overall control of symptoms of a social anxiety disorder (SAD).
SAD is on the rise post-COVID, impacting roughly 23.7 million people across the United States, the company told Benzinga in an email statement.
With FDA feedback confirming the acceptable use of the LSAS as a primary efficacy endpoint, Vistagen is positioned to finalize key components of its potential marketing application-enabling development program for fasedienol for SAD.
The company also plans to include a second LSAS-based Phase 3 study and an open-label long-term safety study in its potential NDA-enabling FEARLESS Phase 3 program for fasedienol in SAD.
The company plans to have further protocol discussions with the FDA regarding additional dosing study(s), which the company plans to conduct in parallel with FEARLESS-1 and potentially before the commencement of the second LSAS-based Phase 3 study.
Vistagen has decided to close the PALISADE-2 study given the expense, time, and methodological complexities involved in resuming PALISADE-2 after failed Phase 3 PALISADE-1 trial.
Vistagen will focus resources primarily on the planning and preparation for FEARLESS-1 Phase 3 study. Topline results from the 140 subjects who completed PALISADE-2 are expected in the second half of 2023.
Last week, the company said long-term intranasal administration of fasedienol up to four times per day in daily life was safe and well-tolerated in nearly 500 SAD patients.
Price Action: VTGN shares are down 4.45% at $0.13 on the last check Thursday.

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