Single-Entity Hydrocodone—Why All the Fuss?

The next (June 9) issue of The Medical Letter will include an article on a new extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER) for treatment of severe chronic pain. Surprisingly, Zohydro ER is the first single-entity formulation of hydrocodone to be marketed in the US. That is surprising because hydrocodone combined with acetaminophen (Vicodin, and others) is the most prescribed drug in the US, which is a little scary. Moreover, according to the CDC, the number of prescriptions written for opioids in general in the US has increased ten-fold since 1990. And we don’t need the government to tell us that the population is not growing that fast.

The FDA’s approval of extended-release hydrocodone has caused a great deal of controversy. For one thing, an FDA advisory committee voted overwhelmingly against the approval, apparently because of concerns about abuse. It is unusual for the FDA to go against a strong vote from one of its advisory committees. According to an article in the May 29 issue of The New England Journal of Medicine, the agency did so at least partly to reduce the risk of acetaminophen hepatotoxicity from all that Vicodin.

Zohydro ER is not, of course, the only extended-release oral opioid on the US market, and our article lists the others. Part of the fuss about this one comes because it was marketed without any abuse deterrent properties. One of the others, Oxycontin, was reformulated last year to make it less abusable; the tablets are now difficult to crush, break, or dissolve, and if the contents are nevertheless added to water, they form a hydrogel that would be difficult to inject. A March 22, 2010 article in The Medical Letter reviewed a combination of extended-release morphine with an indigestible form of the opioid receptor antagonist naltrexone that would be released if the capsules were crushed, chewed, or dissolved in an effort to release all of the morphine at once.

Zohydro ER is a different story. Learn more in our next issue about what’s causing all the fuss.

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  1. Although a single entity hydrocodone may be useful in avoiding acetominophen toxicity, the lack of abuse deterrents seems to me a way for the pharmaceutical company to step into the hugely peofitable illegal drug trade. Is this intentional?

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