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In the news is a powerful new prescription painkiller that The Food and Drug Administration is trying to decide whether it should be approved. This new drug is called Moxduo and it’s not exactly new; it’s a combination of two already-established drugs: morphine and oxycodone in one capsule. It was designed to relieve severe pain quickly, however with fewer side effects than other opiate painkillers.

Moxduo is the result of the first time these 2 drugs have been combined, as far as in a legitimate, medical way. “It’s designed to provide quick relief to patients suffering severe pain from accidents or surgeries,” says Ed Rudnic, COO of QRxPharma, the company that makes Moxduo.

Rudnic asserts that the benefits of Moxduo are that it allows the patient to take lower doses of the two narcotics – morphine and oxycodone, it’s two ingredients – than they’d need if they took either of the medicines alone as well as with fewer side effects.

“We believe that we’ve achieved some benefit in reducing the risk of some of the respiratory complications of these strong opioids,” he says.

But just like with any other opiate painkiller and illicit opiates such as heroin, the most serious risks associated with Moxduo are suppressed breathing and other respiratory complications, which is what leads to fatal overdoses.

Dr. Joseph Audette of Harvard Medical School is not convinced the company has yet proved that Moxduo has fewer side effects.

“They haven’t really done the hard work of absolutely showing … in humans with real pain problems that synergy is making a big difference,” Audette says, “compared to just using the agents that we [already] have available.”

Andrew Kolodny, an addiction specialist at Phoenix House as well as leading member of the Physicians for Responsible Opioid Prescribing, which is fighting for tighter control of prescription painkillers, has his misgivings, too. “I have serious concerns about this product.”

Millions of people are addicted to these legal narcotics already, Kolodny says, with thousands dying from overdoses each year. Drugs like Moxduo will only make that worse.

“This is pure morphine and pure oxycodone,” he says. “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.” Kolodny gives examples of other narcotic painkillers that already exist and that contain multiple other ingredients that make them difficult to abuse in those ways. Drugs such as Vicodin and Percocet are prescription painkillers already in use that are made in such a way as to deter abuse and would be Moxduo’s competitors. Kolodny added that patients requiring treatment for pain issues already have plenty of options and said that a marketing push to prescribe Moxduo could spell trouble.

“If they get this product put on the market and are able to have a sales force going in and out of doctors’ offices encouraging prescribing with the marketing claim that this is somehow a safer product … I believe that’s likely to exacerbate an already severe public health crisis,” Kolodny added.

Rudnic, on the other hand, argues that QRxPharma already has good evidence that Moxduo is a safer painkiller with fewer side effects. And he denies that Moxduo is easier to abuse.

Rudnic said that his company will set up a system to quickly spot any signs that Moxduo is being misused and further said that the manufacturer is already developing a version of the drug that would make it harder to abuse.

FDA Committee on Moxduo

An FDA advisory committee held a day-long hearing Tuesday to decide whether to recommend FDA approval of the drug. The outcome: all 14 members of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously against recommending approval of Moxduo.

This is the second time the agency has shot down Moxduo, the first time being in August.

The committee members said they failed to see enough evidence that Moxduo is safer than either morphine or oxycodone alone for the treatment of moderate to severe acute pain. “It is the sense of this committee that the applicant has not provided sufficient evidence to support a claim that Moxduo is safer than morphine or oxycodone,” Chairperson Randall Flick, MD, MPH, of the Mayo Clinic in Rochester, MN stated. “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.”

The FDA has until May 25th to decide whether to approve Moxduo.

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