Full Statement from Zogenix

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Zogenix Supports Commissioner Hamburg for Reiterating the Necessity of Zogenix Among a Very Important Niche Patient Population Zogenix is committed to ensuring the safe, effective and responsible treatment of chronic pain patients. Zohydro ER (hydrocodone bitartrate) extended-release capsules, is the first available extended release hydrocodone product without acetaminophen for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, and was approved by the U.S. Food and Drug Administration (FDA) after an extended, 18-month, comprehensive review process.  Zogenix is confident in the FDA review process and the decisions made by the agency. FDA Commissioner Margaret Hamburg recently stated that the agency believes that Zohydro ER serves an "important and unique niche" for treating pain. As part of our broad ongoing educational efforts to support appropriate use of prescription medications, Zogenix is implementing best-in-class innovative strategies to support the appropriate use of Zohydro ER today. For example, the company has a number of programs in place to ensure access to safe storage mechanisms, including complimentary access to locking pill caps that encourage patients to practice at-home safekeeping of their prescribed quantity of Zohydro ER. Also, the company already is working with the FDA to develop an effective abuse deterrent technology. As part of that effort, Zogenix is fully engaged in simultaneously developing two potential abuse deterrent formulations of Zohydro ER, which are expected to be available to patients in October 2016. Zogenix has always been, and will continue to be, committed to the chronic pain patient and ensuring they have appropriate access to safe and effective therapies to manage their pain.