A FDA advisory panel recommended that the administration not approve a new pain drug called Moxduo that combines morphine and oxycodone. The panel voted 14 to zero against the approval of the drug.
QRXPharma developed the combination pill with a goal to decrease dangerous side effects of prescription painkillers, such as breathing problems and vomiting. But the panel agreed that there was no data proving the drug was safer than taking morphine and oxycodone separately.
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.