VistaGen Therapeutics gets FDA fast track for non-opioid pain med

VistaGen Therapeutics announced that the FDA has granted fast track designation for development of AV-101 as a non-opioid, non-sedating treatment for neuropathic pain. This is the second fast track designation granted to VistaGen since December 2017. VistaGen’s receipt of the 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.

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