By Colin Kellaher

Avenue Therapeutics Inc. on Friday said the U.S. Food and Drug Administration's neuroscience division has denied the company's appeal of the agency's second rejection of its application seeking approval of intravenous tramadol for the management of post-operative pain.

However, the New York specialty pharmaceutical company said it will continue to pursue regulatory approval of the drug.

Avenue in June said the FDA had turned away its application for IV tramadol for a second time, saying that 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 the company last month filed a formal dispute resolution request with the FDA.

While the FDA has now denied the initial request, Avenue has the option to appeal the matter to the next higher appeal level, through a fourth and final appeal.

Shares of Avenue were recently down 1.6% to $1.68 after hitting a new 52-week low of $1.53 earlier in the session.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

08-27-21 1123ET