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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for Zohydro ER Extended-Release Capsules in 2015 to include abuse deterrence claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids Evaluation and Labeling.
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September 18, 2014
16:27 EDTZGNXZogenix gets exclusive licensing for Zohydro ER from Daravita
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08:40 EDTZGNXZogenix reports new data shows Zohydro ER reduced pain, improved function
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