Vistagen Receives FDA Fast Track Designation for Development of PH10 to Treat Major Depressive Disorder

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, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of PH10, one of the Company’s investigational nasal sprays, for the treatment of major depressive disorder (MDD). The FDA’s Fast Track program facilitates the expedited development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs, with the intention to bring promising new medicines to patients sooner.

“Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression. 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,” stated Shawn Singh, Chief Executive Officer of Vistagen. “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.”

The FDA’s decision is informed by the results of Vistagen’s nonclinical studies and three prior clinical studies of PH10, including a Phase 2A clinical study in MDD. At a 6.4 μg dose administered intranasally twice daily for 8 weeks in the published randomized, double-blind, placebo-controlled parallel design Phase 2A study of PH10 in MDD, PH10 significantly reduced depressive symptoms as early as one week based on the 17-item Hamilton Depression Scale (HAM-D-17) scores compared to placebo (p = 0.022). PH10 was well-tolerated and did not cause psychological side effects (such as dissociation or hallucinations) or other safety concerns that may be associated with other approved pharmacological therapies for MDD. More information about the PH10 Phase 2A study in MDD can be found in the peer-reviewed article, A Placebo Controlled Trial of PH10: Test of a New Rapidly Acting Intranasally Administered Antidepressant, published in the November-December 2019 edition of the British Journal of Pharmaceutical and Medical Research. For more information on the FDA’s Fast Track designation, please visit https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerat ....