VistaGen Gets FDA Approval to Begin Study of AV-101

VistaGen Therapeutics (NASDAQ:VTGN) announced the US Food and Drug Administration authorized the company’s investigational new drug application with a phase 2 clinical study of AV-101.
As quoted in the press release:

VistaGen is preparing to launch a 180-patient, multi-center, double-blind, placebo-controlled Phase 2 study to assess the safety, tolerability and efficacy of AV-101 as an orally administered adjunctive treatment for adult MDD patients with an inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard Medical School will be the Principal Investigator of this study, expected to begin in the first quarter of 2018.
“This is a significant milestone in our AV-101 clinical development program,” stated Shawn Singh, Chief Executive Officer of VistaGen.

Click here to read the full press release.

Source: www.marketwired.com