Vistagen, a biopharmaceutical company, recently unveiled promising preliminary results from a non-peer-reviewed phase 3 trial for the experimental nasal spray fasedienol. This innovative nasal spray demonstrated a significant improvement in clinical social anxiety scores among individuals with social anxiety disorder (SAD). The preliminary data, sourced from the PALISADE-2 trial, indicated that participants who received the first-of-its-kind pherine nasal spray before a stress-inducing public speaking event reported substantial enhancements in Subjective Units of Distress Scale (SUDS) scores compared to those who received a placebo. Patient-reported outcomes also highlighted marked improvements in anxiety measures for the fasedienol-treated group versus the placebo arm.
Vistagen is actively advancing the development of this novel treatment, which holds the potential to become the first therapy approved by the US Food and Drug Administration (FDA) for SAD. Historically, SAD has been inadequately understood and addressed within drug development efforts. Dr. Michael Liebowitz, Director and Founder of the Anxiety Disorders Clinic at New York State Psychiatric Institute, was instrumental in clinically defining SAD half a century ago. In collaboration with colleagues, he identified SAD as distinct from other forms of anxiety, delineating its generalized manifestation characterized by pervasive fear of social interactions, scrutiny, and judgment.
The conception of the Liebowitz Social Anxiety Scale (LSAS) aimed to provide a solid foundation for pharmacological interventions tailored to the unique nature of SAD. While early-generation psychiatric treatments such as selective serotonin or serotonin and norepinephrine reuptake inhibitors (SSRIs, SNRIs) and cognitive behavioral therapy (CBT) were available in the 1980s, little progress was made for SAD patients thereafter. Dr. Liebowitz and associates embarked on a collaboration with Ferring in the mid-2000s to explore a rapid-acting nasal spray agent with potential benefits for psychiatric conditions. Fasedienol emerged as a contender, with Liebowitz recommending its potential application for SAD.
During phase 2 trials, fasedienol underwent evaluations in both staged public speaking events and real-world settings involving socially or performance-challenging situations. Both contexts demonstrated significant efficacy, with the treatment displaying results comparable to 12-week SSRIs improvements in just 2 weeks. Vistagen subsequently partnered with Ferring for late-stage assessments.
The replication of phase 2 results, even with a lower placebo response rate, offers promising potential for advancing fasedienol to market approval. Liebowitz expressed optimism about the clinical significance and magnitude of these results, suggesting that they will contribute to finalizing the phase 3 program and potentially making this novel treatment available to SAD patients.
