VistaGen Therapeutics said that the FDA has agreed to details of a proposed Phase 3 trial of the company’s PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). PH94B was granted Fast Track designation for that indication in December 2019.
According to VistaGen, the Phase 3 trial will include “a single-event, laboratory-simulated public speaking challenge in adult patients with SAD,” similar to a challenge that was used in a Phase 2 study of PH94B for SAD. That study took place from 2008 to 2011 and was sponsored by Pherin Pharmaceuticals, which licensed the nasal spray to VistaGen in 2018. A Phase 3 feasibility study took place in 2015.
VistaGen CEO Shawn Singh explained, “Much like a rescue inhaler is used in an asthma attack or a migraine drug is used in an acute migraine episode, PH94B is a potential fit for the acute treatment of anxiety symptoms in anticipation of an often predictable, anxiety-provoking situation for individuals suffering from SAD. Notably, the FDA concurred that our initial pivotal Phase 3 efficacy study may be conducted in a manner substantially similar to the highly statistically significant Phase 2 study of PH94B, which study involved a single event, laboratory-simulated public speaking challenge in adult patients with SAD. The FDA’s specific guidance will enable us to simplify the process of assessing efficacy among SAD patients in our Phase 3 studies and contribute to significant time and cost efficiency in the clinic.”
The company recently announced that it planned to develop PH94B for COVID-19 pandemic-related adjustment disorder and says that it is continuing preparations for a Phase 2A trial for that indication.
Read the VistaGen Therapeutics press release.
