Zohydro ER gets FDA approval…but will it really help prevent abuse?


On January 30, 2015 the Food and Drug Administration (FDA) approved a reformulated version of Zohydro ER (a long-acting, single-entity hydrocodone product) that is designed to possess abuse-deterrent properties. When the FDA originally approved the medication in October 2013, it was one of the more controversial medication approvals in some time. Yet, despite the objection of over 28 state attorney generals, addiction treatment providers and even the FDA’s own advisory committee, the medication Zohydro ER came to the market in March of 2014.

The new abuse-deterrent formulation is designed to prevent someone from crushing the medication and therefore extracting a large dose of medication to be administered for immediate use as opposed to the long acting effect it was designed for. Zogenix, the manufacturer of Zohydro, developed this new formulation in order to combat the negative image originally created by hydrocodone products. In addition they had to keep up with another long-acting hydrocodone competitor product which just recently came to the market and is already formulated with abuse-deterrent properties, Hysingla (Purdue Pharma).

While abuse-deterrent formulations are helpful in preventing a small population of abusers from inappropriate use, the further addition of more high-cost, long-acting narcotics such as these into the market continues to be a concern for our pharmacy team.

Preventing abuse

What needs to remain in focus is that just because a medication cannot be crushed and abused, doesn't mean risk for abuse and overdose, and a need for patient safety, do not exist. These high-cost medications do nothing to ensure or prevent a patient from becoming addicted to pain medications, from diverting or misusing, and they do not represent a promising option for getting claimants back to work.

At Sedgwick, we work hard to see that the injured workers we service get appropriate care so they can return to work as soon as possible. These new opioid medication approvals, while they may deter abusers, can also serve to distract us from the real conversations of patient safety, wellbeing, and improved patient function that we continue to have with providers every day. Our complex pharmacy management and pharmacy utilization review teams, made up of knowledgeable pharmacists and nurses as well as an in-house physician, will continue to work hard to address the inappropriate utilization of long-term (and short-term), high-cost opioids such as these. Sedgwick is committed to continue to advocate for clinical solutions that are safe, appropriate and likely to get patients back to work as soon as possible. I would welcome your thoughts on preventing abuse of narcotics.

Paul M. Peak, PharmD, Pharmacist, Complex Pharmacy Management

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