FDA Approves New Zohydro ER Formulation

The FDA has approved a new formulation of Zohydro ER,  (hydrocodone bitartrate, Zogenix) Extended-Release Capsules, CII, with BeadTek.

According to a company press release, 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. 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.

“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,”Stephen Farr, PhD, president of Zogenix, said 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.”

Zohydro ER 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.