Zogenix Launches Zohydro ER

Late last week, California-based Zogenix launched its recently approved Zohydro® ER into the U.S. market despite ongoing criticism that the long-acting version of hydrocodone does not possess any notable abuse-deterrent properties. Intended for use in the treatment of pain severe enough to require around-the-clock pain relief and for which alternative therapy options have failed, Zohydro ER is the first long-acting hydrocodone product to hit pharmacy shelves. Until the launch of Zohydro ER, hydrocodone was only available in the United States in combination products with non-opioid constituents (e.g. acetaminophen, ibuprofen, chlorpheniramine, etc.) and was classified as a Schedule III controlled substance; however, Zohydro ER is classified as a Schedule II controlled substance due to its single-entity composition. Many patient safety advocacy groups are concerned about the lack of abuse-deterrent properties of this drug, given the FDA’s recent unpredictable actions regarding the approval of long-acting opioid pain relievers. Zogenix indicates that an abuse-deterrent formulation is currently being developed and may be available within the next three years, pending FDA approval.


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At this point in time, there is no action necessary on behalf of workers’ compensation payors regarding the official launch of Zohydro ER. As your workers’ compensation pharmacy benefits partner, PMSI and Progressive Medical strive to provide you with up-to-the-minute information on medication changes that may affect your patient population. Given increasing concerns over the lack of abuse deterrent characteristics, all Zohydro ER transactions adjudicated against PMSI and Progressive Medical’s formularies will require prior authorization unless otherwise specified at the client level. It is not anticipated that the launch of Zohydro ER will lead to an overall increase in the use of long-acting opioid pain relievers. Based on historical data, it is likely that Zohydro ER will take over a percentage of the market share of currently available long acting opioid products.

Our various pharmacy partners including Kroger, Target, Walgreens, Walmart, Albertsons, Rite Aid, and Safeway have indicated that Zohydro ER will not be auto-stocked at their various locations. Most pharmacies will base future inventory decisions on demand, but can obtain Zohydro ER within a reasonable time period (e.g. overnight to 1-2 days) if a prescription is received at a particular location that does not stock this product.

If you have any questions or need further information, please contact our clinical department directly at clinical@pmsionline.com.

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