ARTICLE | Clinical News

MoxDuo IR morphine/oxycodone regulatory update

April 28, 2014 7:00 AM UTC

FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 14-0 against approval of QRxPharma's MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The panel also voted unanimously that the company did not provide evidence that MoxDuo IR is safer than its individual components at comparable doses. MoxDuo IR, an immediate-release combination of oxycodone and morphine, has a May 25 PDUFA date.

In briefing documents released ahead of the meeting, FDA's Bob Rappaport said the agency's review team has been "unable to conclude that there is a safety benefit" for MoxDuo IR. Rappaport, who is director of the Division of Anesthesia and Analgesia and Addiction Drug Products at FDA's Center for Drug Evaluation and Research, noted that FDA has never approved a combination product comprising two drugs from the same pharmacologic class, which he said is "contrary to the purpose" of the combination rule, which aims to "assure that the combination provides some benefit to patients that could not be obtained by prescribing the individual components alone." ...