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 level.

Avenue on Monday said the Office of New Drugs plans to respond to the company's request within 30 days of the advisory committee meeting.

Avenue shares were recently up 15.1% to $1.45.


Write to Colin Kellaher at


(END) Dow Jones Newswires

October 25, 2021 11:20 ET (15:20 GMT)

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