Vistagen (NASDAQ: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (“CNS”) disorders, has announced favorable safety and tolerability data from its U.S. phase 1 clinical trial of itruvone. “PH10” is the company’s investigational rapid-onset pherine nasal spray for the treatment of major depressive disorder (“MDD”). Results build on successful phase 1 studies and a positive randomized, double-blind, placebo-controlled phase 2A study of itruvone nasal spray in MDD previously conducted in Mexico and enable phase 2B development of itruvone in the U.S. as a stand-alone rapid-onset product candidate for treatment of MDD. “According to a recent Gallup survey, more than a quarter of American adults have been diagnosed with depression at some point in their lifetime. The need for faster-acting, safer and more effective medications is unrelenting, especially in an environment where the gap between innovative treatment options and the prevalence of depressive disorders is increasing,” said Shawn Singh, chief executive officer of Vistagen. “With a successful phase 1 study in the U.S. and a positive phase 2A study conducted outside the U.S. in hand, we look forward to advancing itruvone into phase 2B development in the U.S., on our own or with a partner.”
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About VistaGen Therapeutics Inc.
Vistagen is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders. The company is advancing therapeutics with the potential to be faster-acting and with fewer side effects and safety concerns than those that are currently available for treatment of anxiety, depression and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including five investigational agents belonging to a new class of drugs known as pherines and an oral prodrug of 7-Cl-CYNA, which is a full antagonist of the glycine site of the N-methyl-D-aspartate receptor (“NMDAR”). Pherines, which are administered as nasal sprays, are designed with an innovative rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and selectively impact key neural circuits in the brain without requiring systemic uptake or direct activity on CNS neurons. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression and several other CNS disorders. For more information, visit the company’s website at www.Vistagen.com.
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