At the 2023 Anxiety and Depression Association of America (ADAA) Conference in Washington, D.C., VistaGen Therapeutics, Inc. unveiled new research that further supports the proposed mechanism of action of fasedienol (PH94B), their rapid-onset investigational pherine nasal spray in Phase 3 development for social anxiety disorder (SAD).
The findings suggest that fasedienol is quickly metabolized and cleared from the nasal passages, which helps explain the favorable safety profile of the drug in all clinical studies to date, which have involved over 30,000 doses of fasedienol administered to adults with SAD. This exciting new data from VistaGen could potentially revolutionize the treatment of anxiety and depression, allowing for fast relief with minimal side effects.
In a recent study, researchers extracted cells from the epithelial lining of the nasal passages of healthy adult volunteers. The results of incubating fasedienol with these human nasal epithelial cells showed that, after intranasal spray administration, the P450-CYP enzymes expressed in the nasal epithelial cells and chemosensory cells progressively metabolized and cleared the compound from the nasal passages.
The new study findings provide compelling evidence that fasedienol can activate the neural circuits of the nasal-amygdala area, acting directly on nasal receptors to create rapid anti-anxiety effects.
This means that fasedienol and other fast-acting pherines may offer a promising alternative to existing oral therapies for anxiety, depression and other CNS disorders, which are associated with a number of potential side effects and safety concerns due to their need for systemic uptake. Vistagen’s Vice President of Translational Medicine, Dr. Louis Monti, expressed his enthusiasm for these results, noting that they could lead to the development of novel treatments with fewer risks.
About Fasedienol (PH94B)
Vistagen’s fasedienol (PH94B) is an innovative and groundbreaking pherine nasal spray that promises to revolutionize the treatment of social anxiety disorder. This rapid-onset investigational drug has a unique mode of action that targets the olfactory-amygdala neural circuits of fear and anxiety, while avoiding the systemic distribution, GABA-A receptor potentiation, and direct neuron activity associated with existing anti-anxiety medications.
Intranasal administration in low microgram doses makes this novel MOA fundamentally different from all currently approved treatments, including all antidepressants and benzodiazepines. With a Phase 3 program already underway, fasedienol could offer a desperately needed breakthrough for those suffering from social anxiety disorder.
About Social Anxiety Disorder
Social anxiety disorder (SAD) affects an estimated 25 million Americans, leaving them feeling intense, persistent symptoms of fear in social situations. From making comments in a business meeting to talking to a cashier in a store, everyday activities can cause profound anxiety and fear of embarrassment, judgment, or rejection.
People with SAD may struggle to go to work, attend school, and engage in other interpersonal activities, leading to avoidance behaviors that can significantly impact quality of life. While antidepressants and benzodiazepines are commonly used for long-term treatment, they come with side effects and safety concerns that may make them unattractive to those affected by SAD.
Vistagen is on a mission to revolutionize the treatment of anxiety, depression and other CNS disorders, with the aim of providing faster-acting, more effective, and safer therapies than what is currently available.
Their innovative pipeline of six product candidates includes fasedienol (PH94B), itruvone (PH10), and three investigational pherines – a novel class of drugs that activates chemosensory neurons in the nasal passages to beneficially impact key neural circuits in the brain without systemic uptake. With their commitment to deliver better mental health care and improved outcomes for those living with anxiety and depression, Vistagen is setting the new standard for CNS treatments.