VistaGen Therapeutics Receives FDA Fast Track Designation for Development of AV-101 as a Non-Opioid Treatment for Neuropathic Pain
VistaGen Therapeutics (NASDAQ:VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of AV-101 as a non-opioid, non-sedating treatment for neuropathic pain. As quoted in the press … Continued
VistaGen Therapeutics (NASDAQ:VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of AV-101 as a non-opioid, non-sedating treatment for neuropathic pain.
As quoted in the press release:
“Every day in the U.S., more than 115 people die from overdosing on opioids. We have evaluated AV-101 in multiple models of serious CNS conditions, including those that cause patients to suffer from neuropathic pain, for which current treatment options are inadequate. After considering peer-reviewed data published last year in TheJournal of Pain, together with published safety data from our Phase 1 program, we believe AV-101 has the potential to address the high unmet need for a new non-opioid, non-sedating treatment for neuropathic pain,” said Shawn Singh, Chief Executive Officer of VistaGen. “This important designation is especially timely given the FDA’s forceful commitment to address our nation’s opioid epidemic. The FDA’s Fast Track designation for development of AV-101 for neuropathic pain, together with the previously granted Fast Track designation for major depressive disorder, will allow our team to work closely with the FDA to bring AV-101 to patients affected by two of our country’s most debilitating and widespread healthcare concerns as soon as possible.”
VistaGen’s receipt of the FDA’s Fast Track designation for the development of AV-101 for neuropathic pain comes on the heels of the recent official statement made by FDA Commissioner Scott Gottlieb, stating that the FDA plans to issue guidance documents to assist sponsors with the development of new non-opioid pain medications, such as AV-101, as therapeutic alternatives to the use of opioids. More specifically, over the next 6 to 12 months, the FDA has stated it anticipates issuing several documents intended to stimulate the development of medications for specific types of pain, resulting in smaller clinical trials, faster approvals and quicker launches of novel therapies.