FDA
25th April 2014

FDA Panel Votes Unanimously Against Moxduo Approval

During this meeting on Tuesday, April 22, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) discussed the safety.

FDA Panel Votes Unanimously Against Moxduo Approval

During this meeting on Tuesday, April 22, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) discussed the safety and efficacy for the new drug application (NDA) 203077, proposed trade name MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, submitted by QRx Pharmaceuticals Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. Moxduo is a fixed-ratio, immediate-release combination of morphine sulfate and oxycodone hydrochloride. It represents the first drug combination consisting of two immediate-release opioids. 

In this meeting, there were two discussion questions and two voting questions. The panel voted unanimously against approval for the drug for the treatment of acute pain. Additionally, the panel voted unanimously that Moxduo was not safer than morphine and oxycodone given the available safety data.

The vote relied primarily on the results from “study 022”. This trial involved 375 patients with moderate to severe acute pain after bunionectomy. Its primary endpoint was oxygen desaturation (SpO2 <90% for at least 16 continuous seconds) as respiratory depression is most often the cause of death from opioid overdose.

Randall Flick, MD, MPH, the AADPAC chairperson, noted that “the Applicant has not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone.” Dr. Flick added that the “primary failing” was in study design and the inability of the committee to be able to rely “with confidence” on multiple post-hoc analyses that were performed by QRx Pharmaceuticals. Additionally, many panelists highlighted the fact that Moxduo has a strong potential for abuse, similar to its competitors.

The agency is not obligated to follow its panel’s recommendation, but normally does so.

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