Vistagen (NASDAQ:VTGN) presented positive safety and exploratory efficacy data at the American Society for Clinical Psychopharmacology annual meeting in Miami from its large Phase 3 open-label study of fasedienol nasal spray for the treatment of anxiety in adults with social anxiety disorder (SAD).
The study was conducted with as-needed administrations of fasedienol in adults with SAD when they experienced social and performance stressors in their daily lives.
Long-term administration of 3.2 micrograms of fasedienol, as-needed up to four times per day, was safe and well-tolerated, with no new safety findings or trends identified, regardless of the number of doses administered by each subject. Headache was the most common treatment-emergent adverse event.
More than 30,000 doses of fasedienol were administered by 481 patients during the study.
The study also evaluated the change from baseline in monthly standard clinical measurements and behavioral assessment scales in response to anxiety-provoking social and performance situations in patients’ daily lives after the administration of fasedienol.
“These data advance the body of evidence supporting fasedienol’s safety profile and potential to achieve overall reduction in anxiety for adults suffering with social anxiety disorder,” Shawn Singh, CEO of Vistagen, said in a statement.
“When used as-needed and over time in their daily lives, as in this open-label study and a prior placebo-controlled Phase 2 study, we believe fasedienol, with its exceptional safety profile has the potential to help change the treatment landscape for social anxiety disorder,” he added.
