Zohydro ER: Is the First Hydrocodone-Only Capsule Safe?

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Zohydro ER is an extended-release class II controlled substance used for the management of severe pain that requires around-the-clock treatment. It was approved on October 25, 2013, and will be available for the first time this month (March 2014).

What is different about Zohydro ER?
Zohydro ER is the 1st of its kind! It is the first extended-release hydrocodone ONLY product that does not contain acetaminophen or any other type of analgesic in combination with it.

What strengths are available?
Zohydro ER is available as an extended-release capsule in the following strengths: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg.

How is this medication to be taken?
Zohydro ER is to be taken every 12 hours and is NOT to be used on an as needed basis like other hydrocodone-containing products.

What is the difference between Zohydro ER and Oxycontin, another extended-release narcotic with a similar formulation?

The new formulation of Oxycontin, extended-release oxycodone, is crush-resistant to help eliminate the potential for abuse. Abuse in this case can include—but is not limited to—crushing, snorting, or injecting a medication that is intended for extended-release absorption. Zohydro ER does not have an abuse-deterrent formulation, which may lead to use not in line with the manufacturer’s intended product labeling.

What is the controversy surrounding Zohydro ER?
Zohydro ER has drummed up attention due to the fact that the extended-release hydrocodone product is a powerful narcotic, 5 – 10 times more potent than a similar hydrocodone-containing product, Vicodin. There is concern that an overdose is possible with only a few tablets of Zohydro ER.

Zohydro ER has also been approved without an abuse-deterrent formulation, which could mean that the potential for abusing the product is high. Zohydro ER, unfortunately, is able to be crushed and then snorted or injected due to its current formulation. The FDA advisory committee voted 11-2 against approval of this medication; however, it was ultimately approved by the FDA.

More information on Zohydro ER:

The official product website is currently under construction, but can be found here.
Zohydro ER has a REMS (Risk Evaluation and Mitigation Strategy) program intended to educate patients and healthcare professionals, and reduce the risk of adverse outcomes like addiction or overdose. More information can be found here.

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