Vistagen’s Nasal Spray Shows Promise for Social Anxiety Disorder in Phase 3 Trial

Vistagen’s fasedienol (PH94B) nasal spray for social anxiety disorder (SAD) showed a statistically significant reduction in anxiety measures during a public speaking challenge, using a measure of subjective units of stress score.

The company said the drug is the “first fundamentally new class of medicine for individuals living with SAD in more than 20 years.”

A person with SAD feels intense, persistent symptoms of anxiety or fear in certain social situations, such as meeting new people, making comments in a business meeting, dating, being on a job interview, answering a question in class, or talking to a cashier in a store.

The drug is a first-in-class, rapid-onset investigational pherine nasal spray with a novel proposed mechanism of action that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system.

This phase 3 study used a single administration of the drug in the public speaking challenge, and the company says it plans a future phase 3 study using “multiple administrations of fasedienol over several weeks on a patient-tailored, as-needed basis” to build on these results.

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