FDA approves new Zohydro ER pankiller formulation
- The new version of Zogenix's Zohydro (hydrocodone bitrartate) ER features a new type of abuse-deterrence, Beadtek. But critics say that there aren't enough data to ensure abuse deterrence.
- Beadtek is a technology that turns a drug into a viscous gel if it is crushed and dissolved in liquids or solvents.
- Zohydro ER was initially approved in 2014, much to the chagrin of critics. Although Zogenix implemented a Safe Use Initiative upon approval of the drug, critics claimed that there was still potential for abuse.
When Zohyrdo was approved last year, some critics went so far as to call for the resignation of FDA Commissioner Margaret Hamburg. Their concern is that, without a well-vetted abuse-deterrence feature, the potential for abuse presented by yet another approved ER painkiller outweighed potential benefits. In fact, prescription opioid abuse kills more Americans each year than cocaine and heroin combined, and leads to 420,000 trips to the hospital annually.
However, the FDA noted that Zogenix has been working on providing effectiveness data on the new ER formulation with built-in Beadtek—and that the problem of chronic pain is so severe and so widespread, that approval of additional treatment options is an important part of addressing a longstanding unmet medical need.