VistaGen Depression Study May Proceed

 Vistagen to conduct small U.S. Phase 1 trial with newly optimized formulation of PH10 in Q1 2023 to confirm favorable safety profile from three previous clinical trials and to facilitate Phase 2B development of PH10 for 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 receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA). The letter greenlights a U.S. Phase 1 clinical trial under Vistagen’s newly filed Investigational New Drug (IND) application for clinical development of PH10 in the U.S. as a standalone treatment for major depressive disorder (MDD). The small Phase 1 trial (n=12) will involve the Company’s newly optimized formulation of PH10 and is intended to both confirm the favorable safety profile of PH10 established in three previous clinical studies conducted in Mexico, including a published Phase 2A study for the treatment of MDD, and facilitate Vistagen’s plans for Phase 2B development of PH10 as a stand-alone treatment for MDD.

https://finance.yahoo.com/news/vistagen-receives-fda-study-may-133000535.html