Intranasal Fasedienol Safe, Well-Tolerated in Adults With Social Anxiety Disorder

Repeated, as-needed fasedienol was safe and well tolerated, and improved overall symptom control, in adults with social anxiety disorder (SAD), according to a poster presented at NEI Congress in Colorado Springs, Colorado, earlier this month.

“Fasedienol (PH94B; 3β-androsta-4,16-dien-3-ol) is a synthetic neuroactive steroid from the androstane family of pherines that is administered intranasally and is under phase 3 development in SAD,” wrote first author Jaakko Lappalainen, MD, PhD, of Vistagen Therapeutics Inc., San Francisco, California, and coauthors in the poster abstract. 

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In a previous phase 2 study, fasedienol was well tolerated and reduced anxiety in public speaking and social interaction situations, researchers explained. However, it failed to meet its primary endpoint in a similarly designed phase 3 study that is still under internal review.

The study presented at NEI Congress was a phase 3, open-label study designed to evaluate the safety and tolerability of as-needed fasedienol 3.2 μg (1.6 μg in each nostril) up to 4 times daily over a period up to 12 months. The safety analysis included 481 patients with SAD. Because the study closed early for business reasons unrelated to clinical or safety findings, the average duration of study participation was 121 days; the maximum was 320 days.

Long-term intranasal fasedienol was safe and well-tolerated, according to the study. Some 56.8% of patients had one or more treatment-emergent adverse events (TEAEs), but only about a fifth of them were considered treatment-related. The only TEAEs that occurred in more than 5% of patients were headache (17%) and COVID-19 infection (11.4%). Overall, 38.7% of TEAEs were mild, 16.2% were moderate, and 1.9% were severe — although no severe TEAEs were considered related to fasedienol. TEAEs led to discontinuation in 2.9% of patients.

Researchers identified no relevant changes in electrocardiogram, laboratory, or clinical findings.

In exploratory outcomes, total scores on the Liebowitz Social Anxiety Scale (LSAS) decreased from 93.4 at baseline to 54.4 among 7 patients who remained on treatment at month 9. Average LSAS scores decreased from 91.72 at baseline to 67.59 among 218 patients who remained on treatment through month 3. Fasedienol was also associated with decreased illness severity on the Clinical Global Impression of Severity as well as increased frequency of Clinical Global Impression of Improvement response and Patient Global Impression of Change response over time, researchers reported.

Reference

Lappalainen J, Salman E, Hanover R, et al. A phase 3 open-label safety trial of fasedienol (PH94B) nasal spray in the treatment of anxiety in adults with social anxiety disorder (SAD). Poster presented at NEI Congress; November 9-12, 2023; Colorado Springs, Colorado.