FDA Advisory Committee Votes Against QRxPharma's Moxduo For Acute Pain

QRxPharma announced in a press release that an advisory committee for the Food and Drug Administration (FDA) has voted against Moxduo. The Anesthetic and Analgesic Drug Products Advisory Committee voted 14-0 against approving the opioid prescription painkiller. Moxduo, an immediate release Dual Opioid, is for the treatment of moderate to severe acute pain. The committee found that QRxPharma provided insufficient evidence and did not warrant an approval at this time.

John Holaday, Managing Director and CEO of QRxPharma said, “We are obviously disappointed in the outcome of today’s meeting, but remain confident in the advantages of Moxduo compared to morphine and oxycodone. This is a necessary therapy for patients with moderate to severe acute pain. We are committed to bringing to market safer therapies for pain, such as Moxduo, and preventing opioid abuse.”

Moxduo

Moxduo is a dual opioid — a synergistic pain reliever with fewer side effects than others have — intended as a first-line therapy for acute moderate to severe pain. The company announced in a press release in June of 2013 that the United States Patent and Trademark Office (USPTO) issued Patent #8,461,171 titled “Hybrid Opioid Compounds and Compositions,” giving intellectual property protection until 2031. The patent is for the morphine-oxycodone molecule in Moxduo. Moxduo IR is a combination of morphine/oxycodone in 3mg/2mg, 6mg/4mg, 9mg/6mg, and 12mg/8mg strengths. The 3/2 and 6/4 formulations are not as strong as other opioids on the market. The lower dose makes titrating easier and offers fewer side effects.  

FDA Action

Interested parties can viewing the briefing document that the FDA advisory committee issued in advance of the meeting. The committee reviewed clinical trials and the Moxduo IR New Drug Application (NDA) among other information in order to make its decision. The NDA is a re-filing, submitted in November of 2013. The FDA confirmed prior to the resubmission that Moxduo was shown to be safe and effective. The federal agency requested additional data on the drug’s safety profile, especially the respiratory safety profile. QRxPharma’s Phase III study showed that patients had less severe hypoxia when taking Moxduo compared to morphine or oxycodone alone at equi-analgesic doses.

Respiratory depression results from opioid overdose and causes death and the company states that no other drug has exhibited reduced respiratory risk while providing the same or better pain relief. The committee voted that the company did not prove the respiratory benefits of the drug. Gregory Terman of the University of Washington, one of the committee members said, "I certainly wish that there was an opiate that could be counted on to decrease respiratory depression and maybe one day there will be.”