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Abuse-Deterrent Zohydro ER Approved By FDA

The US Food and Drug Administration (FDA) has approved a new formulation of hydrocodone with abuse-deterrent properties. The new medication is also a hydrocodone only product formulated with BEADTEK, a technology “designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended.”a statement form the Zogenix said.

Zogenix is conducting human trials and studies to see how the medication works, “which will further characterize the abuse-deterrent properties of the new formulation. Zogenix intends to submit these data in the second half of 2015 to the FDA to support an amended product label, including abuse-deterrent claims consistent with the FDS's current draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling.”

Zohydro ER was approved by the FDA in October of 2013. The medication was indicated for the management of pain severe enough to require daily, around the clock, long-term opioid treatment and for which alternative treatment options had failed. Zohydro ER was the first hydrocodone formulation that did not contain acetaminophen, unlike the majority of immediate-release hydrocodone medications. The aim for Zohydro ER was to provide around the clock care and to do so with hydrocodone without the dangers of liver toxicity due to overexposure to acetaminophen.

Zohydro ER's approval by the FDA in October 2013 did not go over well with many health professionals. The approval came against the advice of the FDA's own advisory committee, which expressed concerns for potential of abuse. Since the very start, Zohydro ER has faced major scrutiny, even being banned from being prescribed in the state of Massachusetts.

Numerous states have requested to the FDA that they remove the medication and in September 2014, a coalition of more than 15 consumer groups and medical experts fighting the opioid epidemic called for new leadership at the FDA, charging that the agency's opioid policies are exacerbating the nation's epidemic of opioid addiction and overdose deaths.

In October 2014, Zogenix announced submission of this supplemental New Drug Application for a modified formulation of Zohydro ER designed to have abuse-deterrent properties. The new formulation uses BeadTek, which, the company notes, "incorporates well-known pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents." "Zohydro ER is the only long-acting hydrocodone product administered every 12 hours, and the new formulation maintains the same efficacy and pharmacokinetic profile of the original formulation," the new Zogenix release notes.

The transition from the old Zohydro ER to the new abuse-deterrent formulation is expected to occur in the second quarter of 2015 for all prescribed strengths. Expect the medication to lose it's controversy and fall into place among other prescription painkillers. It is important to note that although abuse-deterrent properties have been added, that does not make the medication completely tamper-proof. All medications have the danger of becoming immediate release. Learn more from your medical doctor about the dangers of your medications.


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