Avenue falls after FDA turns down co's appeal regarding painkiller

Avenue Therapeutics

27/08/2021 15:19

** Shares of drug developer  ATXI.O  fall 5.3% to $1.62 
    ** U.S. FDA turns down co's formal dispute resolution (FDR)
request, submitted in July, regarding the agency's decision to
decline the marketing application for its intravenous
formulation of painkiller tramadol for a second time - SEC
filing (https://bit.ly/3jkEF45)
    ** Shares of ATXI have tumbled ~46.4% since June 14, when
the FDA issued its decision for the second time
    ** The agency in its "complete response letter" says the
delayed and unpredictable onset of analgesia - relief from pain
- with intravenous (IV) tramadol did not support its benefit in
patients with acute pain, adding that data is insufficient 
    ** Co says it intends to continue to pursue regulatory
approval for IV tramadol
    ** An FDR is a pathway through which applicants can seek to
resolve scientific and/or medical dispute, such as deficiencies
cited in a complete response letter
    ** ATXI has fallen 72.8% YTD

 (Reporting by Amruta Khandekar)
 ((Amruta.Khandekar@thomsonreuters.com;))