VistaGen Therapeutics has presented new data from a Phase 3 study of PH94B nasal spray for the treatment of social anxiety disorder (SAD) at the 2019 Anxiety and Depression Association of America (ADAA) Annual Conference. VistaGen acquired the rights to PH948B from Pherin Pharmaceuticals in September 2018.
According to Vistagen, patients who received PH94B experienced a greater reduction in distress within one week than those who received placebo, and patients who received PH94B before crossing over to placebo had a significantly larger reduction in social anxiety as measured by the Liebowitz Social Anxiety Scale (LSAS).
The 4-week Phase 3 feasibility study, which enrolled 22 patients, was completed in March 2015. The company says that it plans to begin pivotal Phase 3 development of PH94B for the treatment of SAD next year, with LSAS developer Michael Liebowitz as principal investigator.
Liebowitz commented, “Social anxiety disorder is one of the most prevalent mental health conditions in the U.S., affecting as many as 15 million Americans. In both Phase 2 and pilot Phase 3 clinical studies, PH94B was more effective than placebo in the whole sample on the primary outcome measure. In the Phase 2 trial, which included both a public speaking and a social situation challenge, PH94B significantly improved the primary efficacy endpoint within 10 to 15 minutes of self-administration. These positive results demonstrate PH94B’s potential to change the lives of millions of people suffering from SAD. I support VistaGen’s plans for a pivotal Phase 3 program launch in 2020. PH94B neuroactive nasal spray has potential to be the first FDA-approved PRN treatment for SAD.”
VistaGen Chief Medical Officer Mark Smith added, “Current treatments for SAD fall far short of patient needs. With its unique mechanism of action, exceptional safety profile and rapid-onset activity, we are excited about PH94B’s potential to transform the current treatment paradigm for SAD. We look forward to working closely with the FDA and Dr. Liebowitz as we prepare for and execute pivotal Phase 3 development of PH94B for SAD.”
Read the VistaGen press release.
