FDA Approves New Formulation of Zohydro
The U.S. Food and Drug Administration (FDA) has approved a new formulation of Zogenix's Zohydro ER (hydrocodone bitartrate). The extended release capsules include BeadTek, which is designed to provide abuse-deterrent properties "without changing the release properties" of the hydrocodone, noted a press release from the company. If crushed or dissolved in a liguid, the Zohydro with BeadTek will "immediately form a viscous gel," rendering it harmless to the user.
The new formulation contains the same "long-acting" formulation of the original Zohydro ER approved in October, 2013. "The new formulation maintains the same efficacy and pharmacokinetic profile of the original formulation," noted the press release.1
"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. "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, according to FDA. Zohydro ER does not contain acetaminophen, unlike many immediate-release hydrocodone products, reducing the risk for potential liver toxicity due to overexposure of acetaminophen, said the company.
In November 2014, the FDA approved Hysingla ER (hydrocodone bitartrate), the second extended-release hydrocodone-only analgesic, but the first with abuse-deterrant properties. Hysingla was designed to be abuse-deterrant by making the tablet difficult to crush, break or dissolve, noted the agency in a press release announcing the drug's approval.2
While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research at the time of Hysingla's approval. “Preventing prescription opioid abuse is a top public health priority for the FDA, and encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain.”
Transition to Zohydro ER with BeadTek is expected to occur in the second quarter of 2015, noted the press release.