FDA approves Zohydro with BeadTek for Pain-Zogenix

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

Concurrently, Zogenix has ongoing Human Abuse Liability studies, 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2015 to the FDA to support an amended product label, including abuse-deterrent claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids � Evaluation and Labeling. Transition to Zohydro ER with BeadTek is expected to occur in the second quarter of 2015 for all prescribed strengths ranging from 10 mg to 50 mg, without disruption to patients currently on therapy.