FDA Approves New Formulation of Zohydro ER

Zogenix Inc. announced that the FDA has approved a new formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules that uses technology that provides abuse-deterrent properties without changing the release properties of hydrocodone when the medication is used properly.

The technology (known as BeadTek) used in the new formulation “incorporates well-known pharmaceutical excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” according to Zogenix.

The company also said the new formulation “maintains the same efficacy and pharmacokinetic profile of the original formulation,” and is expected to be available in the second quarter of 2015 for all prescribed strengths of Zohydro.

However, Zogenix cannot yet include on the Zohydro label any language touting the abuse-deterrent properties of the new formulation. The company is still conducting Human Abuse Liability studies, which it says will “further characterize the abuse-deterrent properties of the new formulation.”

Zogenix said it 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to the FDA “to support an amended product label, including abuse-deterrent claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids — Evaluation and Labeling.”

Stephen Farr, PhD, president of Zogenix, said although the company is “pleased with the outcomes from our safe use initiatives, implemented with the introduction of Zohydro ER last year, we believe moving forward with this formulation change at the earliest possible time is a responsible action for us to take.” He said the company is “committed to completing the ongoing studies to seek additional changes in the product label relating to abuse-deterrent properties by the end of the year.”

Zohydro ER does not contain acetaminophen and 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.