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, is preparing to launch a phase 1 trial of its novel pherine nasal spray for major depressive disorder (“MDD”). The company is anticipating that the trial, which will prepare Vistagen’s drug candidate PH10 for Phase 2b research, will verify PH10’s favorable safety profile, which has been shown in three previous clinical studies. The trial is evaluating VistaGen’s newly optimized formulation of PH10. Because the FDA granted PH10 fast track status last month, the drug is eligible for more frequent meetings and communications with the FDA, which often leads to a smoother development and review process and even an earlier drug-approval date. “Nearly two-thirds of diagnosed and treated depression patients do not achieve remission with first-line therapy,” said Vistagen Therapeutics CEO Shawn Singh in the press release. “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.”
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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 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. For more information about the company, please visit www.VistaGen.com.
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