U.S. FDA declines to approve Avenue's IV formulation of non-opioid painkiller (updated)

Avenue Therapeutics

14/06/2021 17:39

(Updates shares, adds analyst comment)
    June 14 (Reuters) - Avenue Therapeutics Inc  ATXI.O  said on
Monday the U.S. Food and Drug Administration (FDA) declined to
approve its intravenous formulation of non-opioid painkiller
tramadol for a second time, sending its shares tumbling about
38%.
    The FDA has been pushing drugmakers to develop alternatives
to opioid-based painkillers, as the United States grapples with
the menace of opioid addiction. 
    The health regulator in October declined to approve the
intravenous formulation of the painkiller, stating it was not
safe for the intended population.  urn:newsml:reuters.com:*:nGNXb5mkGj
    The agency said on Monday the delayed and unpredictable
onset of analgesia - relief from pain - with intravenous (IV)
tramadol did not support its benefit as a monotherapy to treat
patients with acute pain.  urn:newsml:reuters.com:*:nGNX1fj6R
    There was also insufficient data to support that IV tramadol
was safe and effective in combination with other drugs, FDA said
in its decision that came in more than two months after the
scheduled date of April 12.
    H.C. Wainwright analyst Joseph Pantginis, however, says that
IV tramadol could still have a path forward.
    The FDA did not mention any "chemistry, manufacturing and
controls (CMC)" issues in its complete response letter, Avenue
said, adding that it disagreed with the agency's decision and
would continue to seek regulatory approval for IV tramadol.
    Tramadol was approved in the United States in 1995 as a
non-controlled analgesic, under the trade name of Ultram, to be
sold by drugmaker Johnson & Johnson  JNJ.N .

 (Reporting by Trisha Roy in Bengaluru; Editing by Rashmi Aich
and Shinjini Ganguli)
 ((Trisha.Roy@thomsonreuters.com; within U.S. +1 646 223 8780,
outside U.S. +91 80 6182 3635;))