The US FDA previously granted fast track designation for fasedienol for the acute treatment of social anxiety disorder. Credit: mojo cp / Shutterstock.

US-based biopharmaceutical company Vistagen has enrolled the first participant in its Phase III PALISADE-4 clinical trial of fasedienol as an acute treatment for social anxiety disorder (SAD).

The multicentre, placebo-controlled trial will assess the efficacy, safety and tolerability of fasedienol when given to adults with SAD during a public speaking challenge in a clinical setting.

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Fasedienol is an investigational neuroactive pherine nasal spray thought to have the potential to regulate the olfactory-amygdala neural circuits of fear and anxiety, as well as attenuate the tone of the sympathetic autonomic nervous system.

The study will enrol nearly 236 adults aged 18 to 65 years, who will be randomised at a 1:1 ratio to receive either fasedienol or a placebo.

It follows a similar design to the Phase III PALISADE-2 trial, which previously reported positive data.

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The trial’s primary outcome measure is the Subjective Units of Distress Scale (SUDS), a self-rated assessment by patients.

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PALISADE-4 will also have an open-label extension phase to assess the drug’s long-term safety and tolerability in a real-world setting for up to 12 months.

Vistagen CEO Shawn Singh said: “With the initiation of PALISADE-4 as planned, we have achieved another important milestone in our registration-directed PALISADE Phase III programme for fasedienol, which has the potential to deliver a transformative acute treatment option to over 30 million Americans suffering from the debilitating effects of SAD, including increased risk for depression, alcohol abuse, and suicide attempts.”

Earlier this year, Vistagen enrolled the first patient in the Phase III PALISADE-3 trial of fasedienol for SAD treatment.

The company believes that favourable results from either the PALISADE-3 or PALISADE-4 trials, along with the PALISADE-2 data, could provide substantial evidence of fasedienol’s effectiveness.

This could support a potential new drug application submission to the US Food and Drug Administration for the acute treatment of SAD.