Avenue Therapeutics stock fell more than 50% after the U.S. Food and Drug Administration (FDA) failed to approve an application for IV tramadol drug, according to press release. FDA says that although pivotal Phase 3 clinical trials are statistically significant, it cannot approve the application in the present form since IV tramadol is not safe for the intended patient population. 

  • Avenue Therapeutics is committed to meet with FDA to resolve issues raised and facilitate the new medicine approval. 
  • An adequate terminal sterilization validation needed before New Drug Application (NDA) approval, planned for later in the quarter.
  • FDA did not identify a safety signal in Avenue’s clinical development program

Avenue Therapeutics stock declining on the Complete Response Letter by FDA. ATXI: NASDAQ is down 57.55%.