VistaGen Therapeutics (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 received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) for the development of its proprietary investigational nasal spray: PH10. The designation can expedite development of PH10 as a potential treatment of major depressive disorder (“MDD”) in adults. The FDA designation enables accelerated development and review of new drugs that show potential to address unmet medical needs and are designed to treat serious or life-threatening conditions. PH10 is an investigational pherine nasal spray with a potential rapid-onset mechanism of action (“MOA”) that is differentiated from the MOA of approved treatments for depression disorders. “Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression,” said Vistagen CEO Shawn Singh in the press release. “The FDA’s grant of the Fast Track designation for the development of PH10 in major depressive disorder is a significant regulatory milestone, aligned with our belief in PH10’s potential to improve the standard of care in a significant market where new and differentiated treatments are urgently needed. Nearly two-thirds of diagnosed and treated depression patients do not achieve remission with a first line therapy. With 21 million adults in the U.S. suffering at least one major depressive episode in the past year, potentially millions of individuals are not getting the help they need. We look forward to working with the FDA’s Fast Track program as we advance development of PH10 in the United States.”
To view the full press release, visit https://ibn.fm/HrDDP
About VistaGen Therapeutics Inc.
VistaGen is a late clinical-stage CNS-focused biopharmaceutical 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. Vistagen’s clinical-stage candidates are targeting multiple forms of anxiety and depression. PH94B and PH10 belong to a new class of drugs known as pherines, which are odorless and tasteless investigational neuroactive steroids designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression — one mind at a time. For more information about the company, please visit www.VistaGen.com.
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