Government and Regulations

Abuse-deterrent formulation of extended-release hydrocodone approved


 

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A new formulation of extended-release hydrocodone with abuse-deterrent properties has been approved by the Food and Drug Administration, the manufacturer, Zogenix, has announced.

The new formulation, marketed as Zohydro ER, contains extended-release hydrocodone with “pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to the Jan. 30 statement released by the company. The technology is called “BeadTek.”

The company expects to start transitioning from the currently available Zohydro ER product to the newly formulated product in the second quarter of 2015 for all the prescribed strengths of Zohydro ER, to avoid disrupting patients who are being treated with the product, the statement said.

Zohydro ER is an opioid agonist approved 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,” according to the prescribing information.

In the second half of this year, the company plans to submit the results of ongoing Human Abuse Liability studies, “which will further characterize the abuse-deterrent properties of the new formulation” and will support the addition of abuse-deterrent claims to the prescribing information, the company statement said. The statement refers to the FDA’s draft guidance for the evaluation and labeling of abuse-deterrent opioids, which describes the abuse-deterrent claims.

Zohydro ER was approved by the FDA in 2013.

emechcatie@frontlinemedcom.com

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