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FDA Approves Zohydro ER With Abuse-Deterrent Properties

The FDA has approved a new formulation of Zohydro ER (hydrocodone bitartrate, Zogenix) extended-release capsules. The new formulation contains abuse-deterrent properties using the proprietary technology BeadTek.

Zohydro ER is indicated for patients with severe pain that requires daily, around-the-clock, long-term opioid treatment and in cases where other treatment options are inadequate. It will be available in the second quarter of 2015 in dosage strengths from 10 to 50 mg. Zohydro ER does not contain acetaminophen and is to be taken every 12 hours.

BeadTek is designed to provide abuse-deterrent properties without affecting the release of hydrocodone when used as intended. The medication will form into a viscous gel when crushed or dissolved in liquids or solvents.

"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 Stephen Farr, PhD, president of Zogenix, 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 was the first extended-release hydrocodone without acetaminophen approved by the FDA.

Source: www.painmedicinenews.com