Nasal Spray Shows Remarkable Efficacy in Easing Social Anxiety: Vistagen's Fasedienol Promises New Hope
Californian biopharmaceutical company Vistagen have announced positive results from their Phase III trial of a nasal spray designed to combat social anxiety.
The trial, PALISADE-2, tested efficacy, safety, and tolerability of the compound fasedienol (developmental name: PH94B) to treat patients with acute social anxiety disorder (SAD).
The results of the trial showed that the drug had achieved its primary endpoint: to exhibit a statistically significant improvement in stress during a public speaking challenge. Patients were assessed using the SUDS (subjective units of distress scale) metric, a self-reported 1-100 meter of subjective anxiety.
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Another metric was used to test the medicine’s secondary endpoint: the CGI-I scale (clinical global impression - improvement), whereby a clinician assesses the improvement of a patient’s condition on a seven point scale. Again, fasedienol had a statistically significant improvement in this endpoint when compared to the placebo group.
Furthermore, the trial suggested the favourable tolerability and safety profile of the drug.
“We are thrilled that these compelling top-line results from the Phase 3 PALISADE-2 trial confirm what was seen in the Phase 2 studies in social anxiety disorder and highlight the potential for fasedienol, with its novel and unique proposed mechanism of action, to transform what is possible for more than 25 million people living with social anxiety in the U.S. and millions more affected worldwide,” stated Shawn Singh, Chief Executive Officer of Vistagen.
Fasedienol is the first drug candidate of its kind to exploit its particular mechanism of action. It’s a rapid-onset investigational pherine nasal spray that works by regulating the olfactory-amygdala neural circuits. Herein, it can attenuate the sympathetic autonomic nervous system (or, fight or flight response) without the need for systemic uptake or targeting neurological pathways in the CNS.
Singh said: “As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas. At the head of that class, fasedienol’s potential, as demonstrated in this Phase 3 trial, sets the stage for the first fundamentally new class of medicine for individuals living with SAD in more than 20 years.”
The current therapies that are prescribed for anxiety are benzodiazepines, SSRIs, and beta-blockers, that regulate anxiety via systemic targeting of the CNS or SNS.
As a result of these positive results, the company saw its stock rise by 1,272% on Monday but has since levelled out around 13.00 USD.
This new trial and data appear after the failure of the drug in a previous phase III, trial PALISADE-1. Independent biostatisticians were brought in to assess the study of fasedienol and PALISADE-2, which led to talks with the FDA on the trial’s design.
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