Zogenix (ZGNX)

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Item 8.01 Other Events.
On January 30, 2015, the U.S. Food and Drug Administration (“FDA”) approved a new formulation of ZohydroTM ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™. 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, Inc. 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2015 to the FDA to support an amended product label, including abuse-deterrent claims consistent with the FDA’s current draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling.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.