VistaGen Therapeutics, Inc., a late clinical-stage biopharmaceutical company specializing in neuroscience, has announced its upcoming participation at the American Society of Clinical Psychopharmacology Conference in Miami Beach, Florida, taking place from May 28 to 31, 2024. VistaGen will be presenting research on two investigational pherine nasal sprays: fasedienol and itruvone, which are in Phase 3 and Phase 2 development, respectively, for treating social anxiety disorder (SAD) and major depressive disorder (MDD).
Presentation Schedule
The company will showcase two posters on Wednesday, May 29, 2024, at 11:15 a.m. Eastern Time. The first poster, titled "Fasedienol (PH94B) Nasal Spray for Acute Treatment of Social Anxiety Disorder (SAD): Results from the PALISADE-2 Phase 3 Trial," will be presented by a team including Michael R. Liebowitz, MD, and Ester Salmán, MPH, among others. The second poster, "Brain and Peripheral Tissue Distribution of Intranasal Radiolabeled Itruvone (PH10) in Laboratory Rats," will feature authors Jo Cato, PhD, and Ross A. Baker, PhD.
Fasedienol Nasal Spray
Fasedienol (PH94B) is currently in Phase 3 trials for the acute treatment of SAD. This investigational nasal spray is unique in its mechanism of action, which activates receptors in peripheral nasal chemosensory neurons. This activation triggers neurocircuitry involving the olfactory system and limbic amygdala, bypassing the need for systemic absorption and direct brain interaction. This rapid-onset approach positions fasedienol as a potential first FDA-approved acute treatment for SAD. The U.S. FDA has granted Fast Track designation to fasedienol, underscoring its potential significance in addressing unmet medical needs in SAD treatment.
Itruvone Nasal Spray
Itruvone (PH10) is being developed as a Phase 2 investigational pherine nasal spray for moderate to severe MDD. Its mechanism involves the regulation of neural circuits between the olfactory system and the amygdala, stimulating the limbic-hypothalamic sympathetic nervous system and increasing catecholamine release. This approach aims to offer antidepressant effects without the systemic absorption or brain receptor binding required by current treatments, potentially reducing side effects and safety concerns. Itruvone also has Fast Track designation from the U.S. FDA for its potential in treating MDD.
About VistaGen
VistaGen Therapeutics, listed on Nasdaq as VTGN, focuses on pioneering treatments for psychiatric and neurological disorders. The company’s pipeline includes five clinical-stage candidates from a new class of drugs known as pherines, which are designed to activate chemosensory neurons in the nasal passages and influence brain neural circuitry without systemic absorption. VistaGen's sixth candidate is an oral prodrug aiming to modulate NMDA receptor activity. The company is committed to providing innovative treatments to set new standards of care for those with anxiety, depression, and other neurological conditions.
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