Zohydro™ ER Launch Date Approaches as the Public Petitions the FDA to Retract Approval

Following its approval by the Food and Drug Administration (FDA) on October 25, 2013, Zohydro™ ER became the first extended-release hydrocodone only pain reliever available in the United States. Previously in the United States hydrocodone was only available in combination products with non-opioid constituents (such as acetaminophen and ibuprofen).

Although the FDA appeared to be on a path of requiring all new opioid products to have abuse-resistant or deterrent features, Zohydro ER does not possess any abuse deterrent properties. This notwithstanding, the FDA does indicate that post-marketing surveillance studies regarding the medication’s susceptibility to abuse, addiction, and misuse will be required and a Risk Evaluation and Mitigation Strategy (REMS) will be required in accordance with their 2012 mandate. Zogenix, the manufacturer of Zohydro ER, also indicates that an External Safe-Use Board consisting of pain specialists and addictionologists has been developed to aid in this task and to ensure that all safety data are considered and presented to the manufacturer’s board of directors. The manufacturer further indicates that an abuse-deterrent formulation is currently being developed and will likely become available within the next three years pending FDA approval.

With release imminent, various consumer advocacy organizations, including Public Citizen’s Health Research Group, are urging the FDA to revoke the October 2013 approval citing concerns over public safety and potential misuse and abuse. We share the expressed concerns and have completed a comprehensive review of the medication relative to others currently available for the treatment of chronic pain (Zohydro ER is indicated for the treatment of pain severe enough to require around-the-clock analgesic coverage and for which alternative treatment options have not been adequate). Our position is that the risks associated with this new medication likely outweigh the benefit and we are strongly recommending that our customers either exclude this medication from their customized Medication Plans/Formularies or at a minimum require Prior Authorization, as is consistent with our standard approach.

As we start to see this medication prescribed in our population, rest assured we have a comprehensive suite of clinical tools equipped to proactively and effectively manage utilization and cost from first fill through settlement; including but not limited to formulary management, clinical alerts, urinary drug testing, and a comprehensive review of the medical and pharmacy records by clinical pharmacists trained in pain management and workers’ compensation.  In addition, we continue to watch this medication closely and will keep you informed of developments as appropriate. Should you have any questions please do not hesitate to reach out to our Clinical Services team or your Account Manager.

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