VistaGen Therapeutics shares pop after getting fast-track FDA designation for non-opioid pain treatment

Shares of VistaGen Therapeutics Inc (NASDAQ:VTGN) are climbing after being awarded a fast-track designation from the US Food and Drug Administration for a non-opioid pain treatment.

US regulators have awarded the recognition for the development of the San Francisco company’s small molecule therapy AV-101, a non-opioid which treats neuropathic pain without sedation. This is the second FDA fast-track designation granted to VistaGen since December of 2017.

“We believe AV-101 has the potential to address the high unmet need for a new non-opioid, non-sedating treatment for neuropathic pain,” noted VistaGen CEO Shawn Singh in a statement.

This important designation is especially timely given the FDA’s forceful commitment to address our nation’s opioid epidemic.”

Pleased by the announcement, investors sent VistaGen shares up 42% to $2.16.

AV101 is a small molecule NMDA (N-methyl-D-aspartate) receptor glycine B antagonist without sedative side effects. It treats neuropathic pain which affects about 33 million people in the US and is marked by a sensation of steady burning, “electric shock” or “pins and needles” that results in abnormal neuron function.

The FDA fast-tracking program looks to quicken the review process for drugs which treat serious conditions and fill an unmet medical need.

AV101 is also undergoing a Phase 2 trial for patients with major depressive disorder who have failed to respond to standard antidepressant therapy. In addition to neuropathic pain, the FDA has also awarded fast-track status for the development of AV-101 as a potential treatment of major depressive disorder.

VistaGen is a clinical-stage biopharmaceutical company that develops medicines for central nervous system diseases and disorders.

Story by ProactiveInvestors