Abuse-Deterrent Zohydro ER Formulation Gets FDA Nod

The FDA has approved a new formulation of Zogenix's extended-release hydrocodone bitartrate (Zohydro ER) with technology that provides the drug abuse-deterrent properties without changing the release properties of hydrocodone.

The FDA has approved a new formulation of Zogenix’s extended-release hydrocodone bitartrate (Zohydro ER) with technology that provides the drug abuse-deterrent properties without changing the release properties of hydrocodone.

Zohydro ER, an opioid agonist, was approved by the FDA 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. With this latest regulatory nod, Zohydro ER has become the second hydrocodone product to be recognized as having abuse-deterrent properties by the FDA. The first product, Purdue Pharma’s Hysingla ER, was approved by the FDA in November 2014 and launched in the United States last week.

The abuse-deterrent technology, BeadTek, utilizes excipients that immediately form a viscous gel when crushed and dissolved in liquids or solvents. The efficacy and pharmacokinetic profile of Zohydro ER with BeadTek is the same as that of the original formulation.

“While we are very 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,” said Zogenix President Stephen Farr, PhD, in a press release. “We are also 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.”

Zogenix is conducting ongoing Human Abuse Liability studies to further characterize the new formulation’s abuse-deterrent properties. The manufacturer hopes to submit data from these studies to the FDA in the second half of 2015 so that they may include abuse-deterrent claims on an updated product label.

All prescribed strengths of Zohydro ER are expected to transition to the new formulation in the second quarter of 2015 without disruption to patients currently on therapy, according to a Zogenix press release.