Powerful Narcotic Painkiller Up For FDA Approval
Tuesday, April 22, 2014
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, who heads QRX Pharma, 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 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 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's 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 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's being misused. QRX Pharma is also developing a version of the drug, Rudnic says, that would make it harder to abuse.
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