By Matt Grossman
Avenue Therapeutics Inc. said Monday it received a negative response from the Food and Drug Administration in response to its new-drug application seeking approval for intravenous tramadol.
The FDA found that the unpredictable onset of pain relief with use of the drug detracted from its use as a stand-alone drug for patients in acute pain, according to Avenue. There was also insufficient information to support the drug's use in combination with other analgesics as safe and effective for patients.
New York City-based Avenue said it disagrees with the FDA's interpretation of data and it will continue to pursue regulatory approval for the drug.
Avenue's shares were down 4.3% to $4.03 in premarket trade on the Nasdaq exchange after falling 3.4% Friday.
Write to Matt Grossman at firstname.lastname@example.org
(END) Dow Jones Newswires