Amid a Painkiller Abuse Epidemic, Pharmaceutical Company Creates Powerful Combination Painkiller; FDA Disapproves

By Staff Writer

An advisory committee held a meeting in mid-April to discuss whether they should make a recommendation to the Food and Drug Administration to approve a powerful new painkiller.

Moxduo (made by QRxPharma), which combines morphine and oxycodone, would provide fast pain relief for those in moderate to severe pain (especially those who are undergoing a major surgery).

Surprisingly, the powerful painkiller would provide pain relief to patients who cannot take morphine or oxycodone alone—due to breathing complications, nausea, dizziness and vomiting—as Moxduo has a lower rate of respiratory side effects.

Another benefit of the drug is that, because of the strength of the combined opioids, patients could take lower doses of painkiller.

This strength would come at a cost. The biggest concern for experts is that mixing the two opioids would help to worsen the current epidemic of prescription drug abuse. Some researchers suggest that Moxduo could be even easier to abuse than other opioid drugs like Vicodin and Percocet.

Dr. Andrew Kolodny of the Phoenix House discussed his concerns about the painkiller. “This is pure morphine and pure oxycodone [.] This is a product that is very easy to misuse. Very easy to crush and snort or crush and inject. So it’s significantly more dangerous than the products that it would be competing with.”

Public concern about the possibility of Moxduo’s release comes on the heels of the approval (and subsequent release) of Zohydro (another powerful painkiller) in March. Zohydro was met with opposition; however, a federal judge blocked any bans.

After the advisory committee, the FDA agreed that Moxduo should not be released on the market at this time. FDA reviewers were concerned whether the combination of opioids would provide any increased benefit over just taking morphine and/or oxycodone alone. Furthermore, FDA experts disagreed on whether QRxPharma’s studies proved their claims about the effectiveness of the drug.

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