Avenue Therapeutics Shares Rise as FDA Panel to Meet on Appeal
By Colin Kellaher
Shares of Avenue Therapeutics Inc. rose more than 15% Monday
after the U.S. Food and Drug Administration said it would hold an
advisory committee meeting related to the company's appeal of the
agency's rejection of a proposed pain-relief drug.
The New York specialty pharmaceutical company said the FDA's
Office of New Drugs indicated it needs more input from the
committee as it works to reach a decision on Avenue's formal
request for a dispute resolution.
The agency earlier this year turned away Avenue's application
seeking approval of intravenous tramadol for the management of
post-operative pain for a second time, saying the drug's delayed
and unpredictable onset of pain relief didn't support its benefit
as a monotherapy, and that there was insufficient information
showing that the drug in combination with other analgesics was safe
and effective for the intended patient population.
Avenue at the time said it disagreed with the FDA and in July
filed its formal dispute resolution request. The FDA's neuroscience
division in August denied the initial request, but Avenue took its
appeal to the Office of New Drugs, the agency's next higher appeal
Avenue on Monday said the Office of New Drugs plans to respond
to the company's request within 30 days of the advisory committee
Avenue shares were recently up 15.1% to $1.45.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires
October 25, 2021 11:20 ET (15:20 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.