VistaGen's new oral NMDA-agent antagonist AV-101 has won the FDA's second fast-track status

VistaGen Therapeutics is a clinical biopharmaceutical company focused on developing next-generation therapies to treat a wide range of central nervous system diseases and diseases with high medical needs. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has granted the experimental drug AV-101 as a non-opioid non-sedative for the treatment of neuropathic pain fast-track status. It is also VistaGen's second FDA fast track status since December 2017. Previously, the FDA granted AV-101 fast-track status for the treatment of severe depression (MDD).
Neuropathic Pain (NP) affects about 33 million people in the United States (excluding patients with back pain), a type of pain directly caused by damage to the body's sensory nervous system or disease, characterized by clinical characteristics such as spontaneous pain, pain allergies, abnormal pain, and sensory abnormalities. NP is one of the most difficult diseases to treat.
FDA's Fast Track program aims to accelerate drug development and rapid review for serious diseases to address critically unsolved medical needs in key areas. The fast-track status of experimental drugs means that drug companies can interact more frequently with the FDA during the development phase, and may be given priority FDA review after submitting a new drug application (NDA).
AV-101 is an oral biologically available NMDA subject glycine binding point antagonist with no psychological or sedative side effects. AV-101 has the potential to become a new home-based treatment for a variety of central nervous system adaptations with highly unsophedic medical needs.
currently, AV-101 treatment for severe depression (MDD) is in Phase II clinical development. The AV-101 has a novel mechanism of effect (MOA), which means that its MOA is very different from the FDA-approved antidepressants currently on the market. AV101 targets glutamate, the most common neurotransmitter in the brain. Similar to intravenous ketamine injections, AV-101 inhibits NMDA subject activity and is expected to achieve antidepressant effects of ketamine, but oral medication has no side effects or safety problems with ketamine. (Bio Valley)