FDA approves new formulation of Zohydro ER with BeadTek

FDA has approved a new formulation of Zohydro ER (hydrocodone bitartrate, Zogenix) Extended-Release Capsules, CII, with BeadTek, a formulation technology designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended.

BeadTek incorporates well-known pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents

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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. Zohydro ER does not contain acetaminophen. It is administered every 12 hours, and the new formulation maintains the same efficacy and pharmacokinetic profile of the original formulation.

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Concurrently, the manufacturer has ongoing Human Abuse Liability studies, which will further characterize the abuse-deterrent properties of the new formulation. It intends to submit these data in the second half of 2015 to FDA to support an amended product label, including abuse-deterrent claims consistent with FDA’s current draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

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Transition to Zohydro ER with BeadTek is expected to occur in second quarter 2015 for all prescribed strengths ranging from 10 mg to 50 mg, without disruption to patients currently on therapy.