Zogenix (ZGNX)

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Zogenix Submits Modified Formulation of Zohydro(R) ER With Potential Abuse Deterrent Properties for FDA Review

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SAN DIEGO, Oct. 1, 2014 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related and central nervous system (CNS) disorders, today announced it has submitted to the U.S. Food and Drug Administration (FDA) a supplemental New Drug Application (sNDA) for a modified formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, which has been designed to have abuse deterrent properties. The new capsule formulation contains additional inactive ingredients that are intended to make the product more difficult to abuse by injection and nasal insufflation. The Company anticipates a target action date on the supplement during the first quarter of 2015, and, if approved, a transition from the currently marketed product to this new formulation of Zohydro ER in the second quarter of 2015.

Zohydro ER is indicated 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.

"The new technology being added to Zohydro ER represents a meaningful advancement because it incorporates properties designed to deter abuse yet maintain the efficacy of the medication, a central consideration throughout the product's development," said Stephen Farr, Ph.D., president of Zogenix.

Farr added: "While we are pleased to have advanced the new formulation to submission of a sNDA, this represents only one element of the comprehensive approach Zogenix has implemented to assure the appropriate use of Zohydro ER and to minimize the potential for misuse and abuse. We strongly believe that the first line of defense is educating prescribers, pharmacists and patients about the risks, benefits and appropriate use of opioids. We have implemented the FDA's Risk Evaluation and Mitigation Strategy program for extended-release/long-acting opioids and are continuing with our voluntary initiatives to support the responsible commercialization of Zohydro ER. We are pleased that the available surveillance data demonstrate that these efforts are working."

Keeping prescription medicines out of the hands of those who would abuse them is critical to any strategy aimed at stopping diversion, misuse and abuse. With this in mind, Zogenix implemented a number of industry-leading initiatives to promote the appropriate use of Zohydro ER, including providing patients access to free locking bottle caps and discounts for safe-storage units to help safeguard access to medicine in the home. Zogenix also established an independent External Safe Use Board, in place prior to the launch of Zohydro ER, to evaluate several surveillance data streams of potential abuse, misuse and diversion, which is shared with the FDA.

Approved by the FDA in October 2013, Zohydro ER provides a potential solution to patients who could benefit from an every 12-hour extended-release hydrocodone for around-the-clock management of severe chronic pain and who may be at risk for liver damage due to overexposure of acetaminophen, which can be fatal or require a liver transplant.





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