Zogenix intros new formulation for Zohydro ER caps

SAN DIEGO — Zogenix last week announced that the Food and Drug Administration approved a new formulation of the company's Zohydro ER (hydrocodone bitartrate) extended-release capsules, CII, which now includes BeadTek. BeadTek is an abuse-deterrent technology that does not change the release properties of hydrocodone when the drug is being used as intended. 

 

The new formulation of Zohydro ER contains the same effectiveness and phamacokinetic profile of the original formulation, according to the company. Zohydro ER with BeadTek is expected to launch in second-quarter 2015 for all dosage strengths, which range from 10 mg to 50 mg. 

 

"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, Ph.D., president of Zogenix. "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 to treat pain severe enough that it warrants daily, long-term opioid treatment. The drug contains no acetaminophen, reducing the risk for potential liver damage to overexposure.