Vistagen Therapeutics has announced the initiation of its PALISADE-4 Phase 3 clinical trial for fasedienol, an investigational neuroactive pherine nasal spray, aimed at the acute treatment of social anxiety disorder (SAD). This marks a significant step in Vistagen's registration-directed PALISADE Phase 3 program.
The PALISADE-4 trial is designed as a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of fasedienol in alleviating anxiety symptoms in adults aged 18 to 65 with SAD. Participants will undergo a public speaking challenge in a clinical setting to induce anxiety. The trial aims to enroll approximately 236 adults, randomized in a 1:1 ratio to receive either fasedienol or a placebo.
Addressing Unmet Needs in SAD Treatment
Social anxiety disorder affects over 30 million Americans, characterized by intense and persistent anxiety or fear in social situations. Current FDA-approved pharmacological therapies do not include an acute treatment option for SAD, leaving a significant unmet need in managing the condition. Fasedienol offers a novel approach by rapidly activating nose-to-brain neural circuits without systemic absorption, potentially reducing fear and anxiety associated with SAD.
Fasedienol's Novel Mechanism of Action
Fasedienol is designed to regulate the olfactory-amygdala neural circuits of fear and anxiety and attenuate the tone of the sympathetic autonomic nervous system. This mechanism of action differentiates it from currently approved anxiety medications, as it does not involve potentiation of GABA-A receptors or direct activity on neurons in the brain. The U.S. FDA has granted Fast Track designation for fasedienol, underscoring its potential to address a critical gap in SAD treatment.
Trial Design and Endpoints
The PALISADE-4 trial's primary outcome measure is the Subjective Units of Distress Scale (SUDS), a self-rated assessment by patients. The trial also includes an open-label extension phase to evaluate the long-term safety and tolerability of fasedienol in a real-world setting over a period of up to 12 months. Vistagen believes that positive results from either PALISADE-3 or PALISADE-4, combined with data from the PALISADE-2 trial, could provide substantial evidence of fasedienol’s effectiveness, supporting a potential New Drug Application (NDA) submission to the FDA.
Management Commentary
"With the initiation of PALISADE-4 as planned, we have achieved another important milestone in our registration-directed PALISADE Phase 3 program for fasedienol, which has 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," said Shawn Singh, Chief Executive Officer of Vistagen.
