Zogenix Responds to Governor's Action Singling Out Zohydro™ ER in Massachusetts, Encourages Officials to Consider Patient Needs and Effective Class-Wide Measures

SAN DIEGO, April 23, 2014

We fully support appropriate guidelines on the safe use, serious risks, proper storage and responsible disposal of extended-release and long-acting opioid analgesics. Zogenix is following a rigorous program required by the U.S. Food and Drug Administration (FDA) to ensure that Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, CII is used safely and responsibly. Zogenix strongly disagrees with the Governor's decision once again to single out Zohydro ER, when the facts show that the risks of abuse with Zohydro ER are no different than those of most other long-acting opioid products on the market today. For that reason, FDA has required that Zohydro ER adhere to the same strict labeling requirements and same requirement for post-market studies, training programs for prescribers, and Medication Guides for patients as all other long-acting opioid analgesics. Zogenix urges the Governor to respect the carefully designed approach imposed by the FDA, and to address the problem of opioid abuse on a class-wide basis. 

The active ingredient in Zohydro ER, hydrocodone bitartrate, is no more potent than most other opioids. The amount of drug in each Zohydro ER capsule is consistent with, and on a relative basis, lower than that of comparable extended-release opioid products. And, the singular focus on Zohydro ER for not having an abuse-deterrent formulation is misplaced. In fact, there are more than 30 extended-release opioids on the market and only one has an FDA-approved label indicating it has abuse deterrent properties. Most important, no product on the market today addresses the most prevalent form of abuse, taking an excessive number of tablets or capsules. 

Finally, it is important to remember that Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical data. This rigorous FDA review process serves the nation's public health needs, the medical community and those in severe chronic pain.

Zogenix stands ready to work with the State of Massachusetts to help address the serious problem of opioid abuse and to focus, with the Governor and his team, on the root causes of the problem and the solutions most likely to make a difference. Imposing restrictions on one specific treatment, without developing a full understanding of the facts and the causes of the problem, does not serve the public interest.

To read a fair and balanced view of the facts from experts, we refer you to the FDA Commissioner's speech given April 22, 2014 at the Prescription Drug Abuse Summit in Atlanta, Georgia and the American Academy of Pain Management statement on Zohydro ER.

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