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FDA Advisers Vote Against Approving New Opioid Painkiller

Apr 22, 2014
Originally published on April 22, 2014 8:50 pm

A key government panel Tuesday voted unanimously against approval of a powerful opioid prescription painkiller intended to provide faster relief with fewer side effects.

At the conclusion of a hearing, the Food and Drug Administration advisory committee voted 14-0 against recommending that the agency approve Moxduo, the first drug to combine morphine and oxycodone into one capsule.

The committee also voted unanimously that the drug's developer had not proved that Moxduo is less likely to cause potentially life-threatening respiratory suppression than taking morphine or oxycodone alone.

"I certainly wish that there was an opiate that could be counted on to decrease respiratory depression and maybe one day there will be," said Gregory Terman of the University of Washington, one of the committee members.

QRxPharma, the company that developed Moxduo, had argued that the drug would provide fast relief for millions of patients suffering from moderate to severe pain, including accident victims and people undergoing major surgery.

But FDA reviewers raised questions about whether Moxduo provides any benefits over using morphine or oxycodone alone. The FDA's experts disagreed on whether the company's studies show that the drug delivers the intended benefits, which supposedly include better pain relief, fewer side effects or lower risk of life-threatening complications.

Addiction researchers also argued that the drug raises concerns that it could be more easily abused than opioid drugs like Vicodin and Percocet, which could make the nation's epidemic of prescription painkiller abuse even worse.

In a statement, QRxPharma Managing Director and Chief Executive Officer John Holaday said the company was "obviously disappointed" by the vote but remained "confident in the advantages of Moxduo compared to morphine [and remained] committed to bringing to market safer therapies for pain, such as Moxduo, and preventing opioid abuse."

The FDA is not obligated to follow the panel's recommendations, but the agency usually does.

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AUDIE CORNISH, HOST:

Mix some morphine with some oxycodone and it makes for a powerful painkiller. But today, an FDA advisory committee recommended against approving such a drug, one called Moxduo. The manufacturer said it would provide fast relief with fewer side effects. But it raised fears that more people would become addicted and possibly overdosed on pain drugs. NPR health correspondent Rob Stein is here to discuss this. And, Rob, start by telling us more about this drug, how it works, and who it's designed for.

ROB STEIN, BYLINE: Right. It takes - this drug takes these two really powerful narcotics, morphine and oxycodone, and puts them together into the same capsule for the first time. And QRxPharma, which is the drug company that developed it, says that it would provide really fast, really strong pain relief for millions of patients. We're talking about people who maybe had back problems or had surgery for a hip replacement or a knee replacement or maybe cancer surgery and were in really terrible pain. And this would provide really strong, really fast pain relief to them without - with fewer side effects.

CORNISH: But what is the idea on combining them in this way?

STEIN: Yeah. The idea is by taking these two drugs and putting them together, you could take lower doses of each of them than you would need if you took either of them alone. So the idea is that it would be, first of all, safer. They'd be less likely to produce problems breathing, which is the main reason why people - this is the most serious side effect from these drugs. The main reason why people die from overdoses or for other, you know, other reasons from taking too much. Also, that it would produce fewer of these other side effects that can really - like nausea, vomiting, dizziness. They can also cause really severe itching that makes it hard for people to take enough of those drugs to get the relief they need.

CORNISH: Now, given the power of these drugs, I understand some experts were worried about the safety of Moxduo. Can you give us more detail on that?

STEIN: Yeah. Well, there were really a couple of concerns. The first one was whether the company had really made its case, whether really this drug really was safer and really did have fewer side effects. And, in fact, during today's hearings, during the FDA hearing today, the FDA's own advisers were really skeptical, basically saying, you know, we really don't know if they made their case here. And then beyond that, there was really deep concerns among addiction specialists that this drug would be really easy to abuse, that it'd be really easy to crush it, to snort it, maybe inject it. And then that would make the already really bad prescription painkiller abuse problem in this country even worse.

CORNISH: And, of course, like you said, I mean, that's not specific to this drug. It's a problem for all prescription narcotics.

STEIN: Yeah. That's a - this is a huge problem in this country. On the one hand, you have this big problem of prescription painkiller abuse. You have people who are getting addicted, overdosing. It can destroy families. It can destroy entire communities. And it's a huge problem. Millions of people are addicted. Thousands of people are overdosing every year. On the other hand, you have lots of pain patients who are living in terrible pain and they're having a harder and harder time getting access to the drugs they need to really - to deal with this pain.

CORNISH: In the end, the committee voted against approving the drug. Tell us what happened there.

STEIN: Yeah. There had this daylong hearing. They heard from the company, which they made their case, and they outlined what they would do to try to minimize the chances that this drug would be abused. They also heard from the FDA's experts, which I - who I said, you know, were really skeptical. And then they heard from, you know, pain specialists and pain patients who pleaded with the committee to approve this drug, saying we really need as many options as we can get.

And they also heard from families of people who had lost loved ones to overdoses and had loved ones become addicted. And addiction specialists are saying, look, you know, this is just too dangerous to let this drug get on to the market. In the end, the committee voted very clearly unanimously to recommend against approving it, saying that the company just had not made its case.

Now, it's important to note that the FDA does not have to follow this recommendation. It usually does, but doesn't always. And, in fact, it was another prescription painkiller that the FDA recently approved even though another advisory committee had recommended against approving that one.

CORNISH: That's NPR's Rob Stein. Rob, thank you.

STEIN: Oh, sure. Thanks for having me. Transcript provided by NPR, Copyright NPR.