FDA Advisers Vote Against Approving New Opioid Painkiller
Tuesday, April 22, 2014
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 to 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 proven that Moxduo is safer than taking morphine or oxycodone alone.
QRxPharma, the company that developed Moxduo, 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.
The FDA is not obligated to follow the panel's recommendations, but the agency usually does.
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