Positive data announced in phase 3 study of nasal spray for social anxiety disorder

Key Takeaways:

• Long-term use of fasedienol was safe and well-tolerated in nearly 500 individuals with social anxiety disorder.

• Fasedienol demonstrated clinically meaningful reductions in fear, anxiety and avoidance of social and performance situations in daily life.

A biopharmaceutical company has announced positive data from its phase 3 open-label study evaluating the safety and efficacy of intranasal pherine fasedienol for adults diagnosed with social anxiety disorder.

According to a press release from Vistagen, the trial involving 481 individuals found favorable outcomes in primary endpoints with long-term administration of 3.2 µg of fasedienol, up to four times a day, regardless of doses administered by each participant.

Of the patients in the study, 56.8% reported at least one treatment-emergent adverse event (TEAE). A total of 54.9% of patients reported mild to moderate TEAEs, and 1.9% of patients reported severe TEAEs.

The safety and exploratory Liebowitz Social Anxiety Scale (LSAS) results of the study were built on similar results from a previous randomized, double-blind, placebo-controlled phase 2 trial. During that study, self-administration of the drug as needed ahead of potential anxiety-inducing situations was accompanied by a persistent change in overall SAD symptoms, reduction in fear and anxiety, and less frequent avoidance as measured by the LSAS over the course of fasedienol usage.

“We believe these data suggest that studies involving multiple administrations of fasedienol over time, on an as-needed basis at moments when subjects experience real-life, socially stressful situations, most accurately demonstrate the safety and efficacy potential of fasedienol in patients with SAD and reflect the way we believe fasedienol would be used by SAD patients,” Vistagen CEO Shawn Singh said in the release.