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news.The US Food and Drug Administration (FDA) has granted approval for US-based pharmaceutical firm Zogenix's new formulation of Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek formulation technology.
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Zohydro ER is developed to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
BeadTek is designed to offer abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended.
Zogenix president Stephen Farr said: "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.
"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."
According to the company, Zohydro ER with BeadTek will be available in the second quarter of 2015 in all prescribed strengths ranging from 10mg to 50mg, without disruption to patients currently on therapy.
Simultaneously, the company has ongoing Human Abuse Liability studies, which will further characterize the abuse-deterrent properties of the new formulation.
In the second half of 2015, the company plans to submit these data to the FDA to support an amended product label, including abuse-deterrent claims consistent with the FDA’s current draft Guidance for Industry, Abuse-Deterrent Opioids — Evaluation and Labeling.