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FDA Rejects Opioid Painkiller Moxduo … But Why?

A controversial drug known as Moxduo failed to gain approval from the Food and Drug Administration (FDA) in a unanimous 14:0 decision.

The powerful new opioid combines morphine and oxycodone into one instant release tablet. Australian pharmaceutical company QRxPharma, the developers of Moxduo, claims that combining two small doses of opioids reduces the risk of respiratory failure.

FDA representatives have stated that such a powerful combination would exacerbate an already severe opiate abuse problem in the US. Dr. Andrew Kolodny of the Phoenix House told NPR that, “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.”

FDA representatives have stated that such a powerful combination would exacerbate an already severe opiate abuse problem in the US.

The most frequently prescribed painkiller in the US is an extended release form of Hydrocodone. Although extended release tablets contain a higher percentage of opioids, it is more difficult for nonprescription users to tamper with it by crushing, snorting or injecting the drug. For example, the extended release form of OxyContin was declared tamper-resistant by the FDA last year.

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This is the second time the FDA has rejected Moxduo.

QRxPharma is a specialty pharmaceutical company dedicated to developing new painkillers. Moxduo was to be their first medicine on the market. The company remains firm in their stance that they are committed to reducing the risk of opiate abuse. Moxduo is intended for those undergoing severe pain such as people recovering from cancer surgeries or back operations.

In a press release the company’s chief executive John Holaday said, “We are obviously disappointed in the outcome of today’s meeting. We are committed to bringing to market safer therapies for pain… and preventing opioid abuse.”

Meanwhile the FDA has encouraged doctors to try every possible alternative before prescribing opiate painkillers. In 2010 over 12 million Americans reported to the Centers for Disease Control that they had used prescription opiates for non-medical reasons. At least one-half of painkiller overdoses involve a combination with a street drug such as cocaine or heroin.

Also Read: America’s Painful Love Affair with Painkillers