Social Anxiety Disorder Impacts Around 23.7M People In US, Vistagen Releases Details Around Nasal Spray Treatment Program For It - Vistagen Therapeutics (NASDAQ:VTGN)

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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