FDA Approves Abuse-Deterrent Pain Medication

The FDA approved a new formulation of hydrocodone extended-release (ER) capsules with abuse-deterrent properties. The single-entity hydrocodone product, manufactured by Zogenix Inc, will be formulated with BeadTek, a technology "designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when [hydrocodone ER] is used as intended," according to a statement from the manufacturer.

The company is conducting ongoing human abuse liability studies, "which will further characterize the abuse-deterrent properties of the new formulation," the statement notes. "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2015 to the FDA to support an amended product label, including abuse-deterrent claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling."

The FDA first approved hydrocodone ER in October 2013 for the management of pain severe enough to require daily, long-term opioid treatment and for which alternative treatment options are inadequate. It was the first hydrocodone formulation that did not contain acetaminophen, unlike many immediate-release hydrocodone products, with the aim of reducing the risk for potential liver toxicity due to overexposure of acetaminophen. However, the FDA approval of hydrocodone ER came against the advice of its own advisory committee, which expressed concerns about the potential for abuse. The drug has since been a topic of debate, with consumer groups and attorneys general of numerous states asking the FDA to reverse its approval of the drug.

In October 2014, Zogenix announced submission of this supplemental New Drug Application for a modified formulation of hydrocodone ER designed to have abuse-deterrent properties.

"[Hydrocodone 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," according to the news release from Zogenix.