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FDA to consider morphine-oxycodone combo pill

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UPDATE (4/22/14): The Anesthetic and Analgesic Drug Products Advisory Committee voted unanimously (14-0) to recommend against approval of Moxduo IR.

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Government health officials' concerns about acetaminophen-related liver damage have opened the door for sales of one non-abuse-deterrent opioid, and may help to put another dangerous drug on the market.

Because of fears about the liver toxicity of its acetaminophen component, the FDA banned prescriptions of Vicodin containing more than 325 milligrams of acetaminophen per dose in January 2014. Now, the FDA is in the process of moving hydrocodone-combination products such as Vicodin from Schedule III to Schedule II, which means that refills will no longer be included in initial prescriptions. However, the FDA's stated goal is not to place too many limits on chronic pain relief options. With that in mind, the FDA approved Zohydro, a non-abuse-deterrent hydrocodone analgesic, against the 11-2 recommendation of its own panel of anesthetic and analgesic drug experts, in December 2013.

On April 22, 2014, the FDA panel on anesthetic and analgesic drugs will meet again, this time to discuss a drug called Moxduo, developed by QRxPharma. Containing a mixture of morphine and oxycodone in a 3:2 ratio, Moxduo IR (immediate release) contains no abuse-deterrence mechanism. In fact, Moxduo IR represents the first time a drug company has tried to sell a combination of two immediate-release opioids.

Unlike Zohydro, which is marketed for chronic pain, Moxduo IR will be marketed for "moderate to severe acute pain," such as after a root canal or wisdom tooth extraction. The makers of Moxduo believe that the recent and pending changes to Vicodin regulations "level the playing field" for morphine-containing drugs and create an opportunity for a new drug in the acute pain marketplace. In its investor materials, QRxPharma notes an addressable market size of 214 million annual prescriptions for Moxduo IR.

But what effect will this new drug have on the opioid abuse problem in the United States?

The percentage of individuals seeking substance abuse treatment who admitted pain reliever abuse increased more than 400 percent from 1998 to 2008 (from 2.2 percent to 9.8 percent). Non-medical use of pain relievers is second only to marijuana use as a form of illicit drug use in the United States. Mirroring this trend, emergency room visits involving oxycodone increased 152 percent from 2004 to 2008. ER visits involving hydrocodone increased 123 percent, and ER visits involving morphine increased 96 percent, during the same time period.

A few simple calculations yield the troubling fact that at least 12.5 percent of individuals who receive opioid prescriptions either abuse them or pass them on to someone else who uses them for non-medical purposes. With the United States awash in nearly 257 million annual opioid prescriptions each year, it comes as little surprise that nearly 34 million Americans use these drugs non-medicinally.

So where will it end? Will the FDA approve a non-abuse-deterrent pill that contains both morphine and oxycodone? The Allentown Family Health Examiner has invited comment from Governor Deval Patrick of Massachusetts, Attorney General Jack Conway of Kentucky, and the Lehigh Valley's own Andre Stevens of the Northampton County Drug Task Force. There is still time for these public officials to appear at the April 22 FDA advisory committee meeting and share any views they hold regarding the pending approval of Moxduo IR.