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Thursday, April 24, 2014

FDA Panel Votes Against Moxduo

The new drug, Moxduo, is the first medication to combine both an opiate (morphine) and opioid (oxycodone), reports NPR. Both morphine and oxycodone are powerful and highly addictive drugs that have been widely abused in the United States. Combining the two drugs appears to be a recipe for disaster; approval of the drug would surely add to America’s ever growing prescription drug epidemic.

Panel members disagreed on whether studies conducted by the makers of Moxduo showed better pain relief with fewer side effects. The panel was not entirely convinced whether Moxduo had advantages over using oxycodone or morphine on their own, the article notes.

Despite Moxduo’s manufacturer, QRxPharma, claiming that the drug has fewer side-effects than opioids currently available on the market, the FDA’s advisory panel failed to see proof of such claims. The panel stated that QRxPharma had not sufficiently proved that Moxduo was less likely to cause respiratory suppression, a side-effect that is potentially life-threatening. Every opiate/opioid based drugs on the market is known for the side-effect of respiratory suppression, a side-effect that doctors would love to find a way to counter.

“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 panel member Gregory Terman of the University of Washington.

In a statement, QRxPharma Managing Director and Chief Executive Officer John Holaday said, “We are obviously disappointed in the outcome of today’s meeting, but remain confident in the advantages of Moxduo compared to morphine and oxycodone. This is a necessary therapy for patients with moderate to severe acute pain. We are committed to bringing to market safer therapies for pain, such as Moxduo, and preventing opioid abuse.”

The FDA usually follows the recommendations of its panels, but is not required to do so. As we saw with Zohydro ER, the FDA’s panel, as well as countless experts and legislators, were against Zohydro’s approval, but it was approved anyway.
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