Social Anxiety Disorder
Social anxiety disorder (SAD) can be viewed as a series of acute, socially stressful events in which patients exhibit excessive fear of embarrassment, humiliation, scrutiny, evaluation, or rejection by others1. The avoidance, fear, or anxious anticipation of these situations interferes significantly with the person’s daily routine, having a marked impact on occupational functioning and social life. The disorder has a lifetime prevalence estimated at up to 13%, with onset typically in the mid-teens or earlier, and is diagnosed slightly more frequently in females than males. In the absence of social or performance events, patients with SAD are asymptomatic. Patients with SAD are not anxious, except when facing feared social and performance situations.
Social anxiety disorder typically does not resolve naturally, often times leading to alcohol use disorder and major depressive disorder as sequalae2. A key psychotherapy mechanism by which individuals with SAD overcome this condition, or lessen their symptoms, is believed to be by exposing themselves to feared or avoided situations. This is the basis of cognitive-behavioral treatment (CBT) for SAD3. However, it is difficult for most individuals with SAD to even consider entering stressful, anxiety provoking social situations, preventing initiation and gradual increase in exposure to stress, which is necessary for successful CBT.
Vistagen’s Innovation:
Fasedienol has potential as a rapid-onset novel treatment for anxiety in adults with SAD. Results from a placebo-controlled, randomized, double-blind Phase 2 study of fasedienol in a real-world setting suggested that self-administration of fasedienol on an as-needed basis prior to anxiety-provoking situations was accompanied by a persistent change in overall SAD symptoms, reduction in fear and anxiety, and less frequent avoidance, as measured by the Liebowitz Social Anxiety Scale (LSAS), over the course of fasedienol usage. Further, in a large Phase 3 open-label study, the analysis of the final data set demonstrated clinically meaningful functional improvement, as measured by the LSAS, and total LSAS scores continued to decline in consecutive months during the study.
The fasedienol Phase 3 open-label study was designed primarily to evaluate the safety and tolerability of multiple, as-needed intranasal administrations (up to four times a day) of fasedienol in adults with SAD. Safety and tolerability of fasedienol were assessed and summarized during monthly visits from baseline to end of treatment in adverse events (AEs), laboratory values, 12-lead electrocardiograms (ECGs), physical examinations, and vital sign assessments following exposure to fasedienol. At the time of study closure, study participants had a mean trial exposure of 120 days and a maximum exposure of 320 days. Key safety-related results from the study including the following:
- The long-term intranasal administration of 3.2 µg of fasedienol, up to four times a day, as-needed, was safe and well-tolerated in adult SAD patients (n=481).
- Of the 481 SAD patients in the study who received at least one dose of fasedienol, at least one treatment-emergent adverse event (TEAE) was reported by 56.8% of subjects, with 54.9% of the 481 patients reporting mild or moderate TEAEs and only 1.9% of patients reporting severe TEAEs.
- Headache was the most common TEAE (17.0%); no other TEAE occurred in more than 5.0% of subjects, except for COVID-19 TEAEs (11.4%), which were not considered related to fasedienol.
- Fourteen patients (2.9%) experienced a TEAE leading to discontinuation from the study.
- Six patients (1.2%) experienced a treatment-emergent serious adverse event, none of which were considered related to fasedienol.
The FDA has granted Fast Track designation for fasedienol as a potential treatment for the treatment of anxiety symptoms in adults with SAD.
1 Liebowitz, Gorman, Fyer, & Klein, 1985
2 Oliveira LM, 2018
3 Juster & Heimberg, 1995
