Data from Pharmawand - Curated by EPG Health - Date added 15 April 2019
VistaGen Therapeutics announced additional results from a positive pilot Phase III study of PH 94B, a potential first-in-class neuroactive nasal spray shown to be effective on an as-needed (PRN) basis for treatment of social anxiety disorder (SAD). The new data were presented in a poster session at the 2019 Anxiety and Depression Association of America (ADAA) Annual Conference in Chicago.
In the 22-patient, four-week, randomized, double blind, placebo-controlled pilot Phase III crossover study, subjects receiving PH 94B had a significantly greater decrease in average peak Subjective Units of Distress scores compared to placebo within one week of treatment. There was also a significantly greater decrease in Liebowitz Social Anxiety Scale (LSAS) avoidance scores for subjects who received PH 94B first, before crossing over to placebo. Administered at microgram doses and consistent with results from prior Phase II studies, PH 94B's safety profile was excellent, with no serious adverse events. VistaGen is currently preparing for pivotal Phase III development of PH 94B as a novel first-line PRN treatment for SAD, with Dr. Michael Liebowitz, developer of the LSAS, a widely-used primary outcome measure in SAD for both clinical research and for evaluation in clinical practice, acting as Principal Investigator for the study.