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July 2, 2014
07:41 EDTZGNXZogenix updates development of abuse deterrent formulations of Zohydro ER
Zogenix announced an update on its development programs focused on the introduction of abuse deterrent formulations of Zohydro ER Extended-Release Capsules, CII. 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 company has previously indicated that it is simultaneously developing two distinct approaches for abuse deterrent formulations of Zohydro ER. Following a recent meeting with the FDA, Zogenix expects to file a supplemental new drug application, or sNDA, by October for a next-generation formulation of Zohydro ER Extended-Release Capsules designed to make it more difficult to abuse by injection or nasal administration. If approved, this new formulation could be available to prescribers in early 2015. The company will continue to characterize the product's abuse deterrent properties with the goal of further amending the labeling for Zohydro ER Extended-Release Capsules in 2015 to include abuse deterrence claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids Evaluation and Labeling.
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July 14, 2014
08:36 EDTZGNXZogenix announces patent for DosePro Needle-free Delivery System
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July 9, 2014
08:33 EDTZGNXZogenix reports positive development on U.S. District Court ruling
Zogenix commented on the order issued by the U.S. District Court in Massachusetts upholding its prior decision that imposing regulations to restrict access to Zohydro ER Extended-Release Capsules, CII, violates Constitutional law. The court's decision supports the importance of upholding the principle at the heart of this case, which is that the FDA is the only regulatory body that is authorized to determine the approval and access of medicines for all Americans. On October 25, 2013, the FDA approved Zohydro ER 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 today's decision preserves access for those in Massachusetts who may benefit from its medical attributes and sets a precedent for other states seeking to unjustly restrict access to Zohydro ER. Zogenix will continue to work to ensure patients have access to Zohydro ER in every state in a manner that is consistent with all extended-release opioids.

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