On April 22, 2014, the Food and Drug Administration’s Center for Drug Evaluation and Research held a scheduled meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).  One of the main issues discussed and voted on concerned the proposed drug Moxduo, which is developed by QRxPharma and is a combination pain medication made up of morphine sulfate and oxycodone hydrochloride.  The proposed indication was for “the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.”  The “Combination Rule,” which is part of the FDA regulations under 21 CFR 300.50, states that:

“(a) Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug.  Special cases of this general rule are where a component is added: (1) To enhance the safety or effectiveness of the principal active component; and (2) To minimize the potential for abuse of the principal active component.”

The FDA has never approved a combination drug product composed of two drugs from the same pharmacologic class.  See the FDA background materials here.

The AADPAC unanimously voted against approving Moxduo, stating that the studies done by QRxPharma did not show any advantages over regular oxycodone and morphine.  Members of the public who spoke at the AADPAC meeting were concerned about the abuse potential of the pill.

It is important to remember that the FDA is not required to follow the recommendations of the AADPAC, which is exactly what occurred when the AADPAC voted 11-2 against approving Zohydro (long-acting, extended-release hydrocodone, manufactured by Zogenix) in December 2012.  See the Reuters article on the attempted Massachusetts ban here

The concerns of potential opioid abuse as a public health and safety issue, balanced with the need for appropriate patient care, continues to be a major focus for physicians all over our country, including New Hampshire.  It seems that we still don’t have all the pieces figured out yet.  Understanding the process may help all involved.


Stuart J. Glassman, MD

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