VistaGen Therapeutics (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for depression, social anxiety disorder and other central nervous system (CNS) diseases and disorders with high unmet need, announced today additional results from a positive pilot Phase 3 study of PH94B, 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 3 crossover study, subjects receiving PH94B had a significantly greater decrease in average peak Subjective Units of Distress scores compared to placebo within one week of treatment.1 There was also a significantly greater decrease in Liebowitz Social Anxiety Scale (LSAS) avoidance scores for subjects who received PH94B first, before crossing over to placebo. Administered at microgram doses and consistent with results from prior Phase 2 studies, PH94B’s safety profile was excellent, with no serious adverse events. VistaGen is currently preparing for pivotal Phase 3 development of PH94B 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.
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