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Powerful Narcotic Painkiller Up For FDA Approval

Apr 22, 2014
Originally published on April 22, 2014 12:34 pm

The Food and Drug Administration is trying to decide whether to approve a powerful new prescription painkiller that's designed to relieve severe pain quickly, and with fewer side effects than other opioids.

While some pain experts say the medicine could provide a valuable alternative for some patients in intense pain, the drug (called Moxduo) is also prompting concern that it could exacerbate the epidemic of abuse of prescription painkillers and overdoses.

An FDA advisory committee is holding a daylong hearing Tuesday to decide whether to recommend that the agency approve the drug.

Moxduo for the first time combines morphine and oxycodone in one capsule. It's designed to provide quick relief to patients suffering severe pain from accidents or surgeries, such as knee replacements, back surgeries or cancer operations, says Ed Rudnic, COO of QRxPharma, the company that makes Moxduo.

The drug allows patients to take lower doses of the two narcotics than they'd need if they took either of the medicines alone, Rudnic says.

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

Suppressed breathing and other respiratory complications are the most serious risks of these drugs — the main reason people die from taking too much.

Some pain experts think the idea behind Moxduo is a good one. A lot of patients can't take enough morphine or oxycodone to ease their discomfort because of the risk to breathing and other side effects, such as nausea, vomiting, dizziness and severe itchiness.

Patients who could theoretically benefit from such a pill are "normal people like you and me," says Dr. Joseph Audette of Harvard Medical School. "And then suddenly we get in a terrible accident or have surgery and ... we need something. And the typical agents are used, and suddenly all these terrible side effects come up."

But Audette 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."

And some experts worry that Moxduo will come with its own problems.

"I have serious concerns about this product," says Andrew Kolodny, an addiction specialist at Phoenix House. He also leads the Physicians for Responsible Opioid Prescribing, which is fighting for tighter control of prescription painkillers.

Millions of people are addicted to these legal narcotics already, Kolodny says, with thousands dying from overdoses each year. Moxduo, he worries, would 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. He cites Vicodin and Percocet as competing drugs that contain multiple other ingredients (in addition to a narcotic) that make them more difficult to abuse in those ways.

Patients in severe pain already have plenty of options, he says, and 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 tells Shots.

For his part, Rudnic argues that the manufacturer already has good evidence that Moxduo is a safer painkiller with fewer side effects. And he disputes the claims that Moxduo is easier to abuse.

"I understand abuse and I understand the anguish that some of these people have that have lost a loved one to a drug overdose," says Rudnic. "I lost a brother to a drug overdose in 2002 and it was really tough."

Rudnic promises his company will set up a system to quickly spot any signs that Moxduo is being misused. QRxPharma is also developing a version of the drug, Rudnic says, that would make it harder to abuse.

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The Food and Drug Administration is considering whether to approve a powerful new prescription painkiller. It's designed to relieve severe pain quickly with fewer side effects than other narcotics. But there are concerns the drug may actually fuel the nation's epidemic of prescription painkiller abuse.

NPR's Rob Stein has the story.

ROB STEIN, BYLINE: The drug is called Moxduo. Ed Rudnic heads the company that developed it. He says Moxduo could help millions of patients who are in pain for many reasons.

ED RUDNIC: Knee replacement surgeries, hip replacements, neck and back surgeries; you know, think about automobile accidents, construction accidents. Things like that, where you, you know, broken arms, broken legs - things where you are going to be in pain.

STEIN: Here's the idea: Moxduo combines two really strong opioids, morphine and oxycodone, into one capsule for the first time, at lower doses then you'd need if you took them by themselves. That, Rudnic says, is safer than taking higher doses of either of them alone.

RUDNIC: We believe that we've achieved some benefit in reducing the risk of some of the respiratory complications of these strong opioids.

STEIN: And respiratory complications are the biggest danger from these drugs, the main reason people die from taking too much.

Now, some pain doctors think the idea behind Moxduo is a good one. Joseph Audette is a pain expert at Harvard. He says a lot of patients can't take as much morphine or oxycodone as they need because they're risky and have other side-effects - nausea, vomiting, terrible itchiness.

JOSEPH AUDETTE: Who are those people? Its people, normal people like you and me. And then suddenly we get in a terrible accident or we have surgery and then we need something. And the typical agents are used and suddenly all these terrible side-effects come up.

STEIN: But Audette is not convinced the company has really proven Moxduo has fewer side effects.

AUDETTE: They haven't really done the hard work of absolutely showing that in humans with real pain problems, that that synergy is making a big difference compared to just using the agents that we have available.

STEIN: And some experts worry that Moxduo brings its own problems.

ANDREW KOLODNY: I have serious concerns about this product.

STEIN: Andrew Kolodny is an addiction specialist who leads a group that's fighting for tighter control over prescription painkillers. Millions of people are addicted to prescription painkillers already and thousands are dying from overdoses each year. Kolodny says Moxduo would only make that worse.

KOLODNY: 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.

STEIN: Like Vicodin and Percocet, which are hard to abuse that way. Kolodny argues that those drugs and others give patients in severe pain plenty of options.

KOLODNY: What's very likely to happen 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.

STEIN: For his part, Rudnic argues the company has good evidence that Moxduo is a safer painkiller with fewer side-effects. And it's not true it's easier to abuse.

RUDNIC: I understand, you know, abuse. And I understand the anguish that some of these people have that have lost a loved one to a drug overdose. I lost a brother to a drug overdose in 2002 and it was really tough.

STEIN: Rudnic promises his company will set up a plan to quickly spot any signs Moxduo is being abused.

The FDA is convening a panel to take a look at Moxduo today and recommend whether to allow this controversial new prescription painkiller onto pharmacy shelves.

Rob Stein, NPR News. Transcript provided by NPR, Copyright NPR.