FDA Should Reject Application for Moxduo, an Unprecedented Opioid Combination

April 22, 2014  

Update: The advisory committee voted 14-0 to reject Moxduo.

Comment from Dr. Wolfe: The unanimous 14-0 vote to reject the approval of Moxduo is a step forward in public health. By rejecting a drug that has no advantage over existing drugs, the committee is helping curb an expansion of drug addiction and increased deaths from opioid abuse. This gives hope that this rampant epidemic of opioid use will start getting turned around.

FDA Should Reject Application for Moxduo, an Unprecedented Opioid Combination

(Morphine and Oxycodone)

Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group

Note: Dr. Sidney Wolfe today is presenting testimony to the FDA Analgesic and Anesthetic Drug Advisory Committee meeting on behalf of himself and Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing.

The epidemic of prescription opioid overuse continues unchecked, yet here we are contemplating another proposed pain medication – this one combining two opioids. If approved, Moxduo would be the first combination therapy to include two immediate-release opioids.

Moxduo, made by QRx Pharma, should not make it to pharmacy shelves even though the company describes the product as “a significant step toward achieving the Holy Grail of opioid therapy.”

Research shows that Moxduo is not safer or more effective than either of its components when they are taken at proper, equivalent dosages. And if substituted for drugs such as Vicodin, an avowed competitor, it may well be subject to more abuse.

The U.S. already leads the world in oxycodone consumption. It has 4.4 percent of the world’s population but consumes 82 percent (more than 77 tons) of the world’s total annual oxycodone.

Opioid overuse, abuse and death is rampant. The last thing needed is an unprecedented, “new” opioid with no extra benefits for patients. If Moxduo were on the scene, we would most likely see an increase in both U.S. consumption and unintentional deaths.

We strongly urge the FDA not to approve this drug.

View the testimony.

###