Zohydro opposition ramps up
The clamor for the FDA to reverse its October 2013 approval of the pure hydrocodone medication Zohydro ER got louder Wednesday when a group called the FED up! Coalition sent a letter to Commissioner Margaret Hamburg, urging her to overturn the approval.
The petition, which CNN notes is posted at Change.org, is signed by members of healthcare agencies, addiction treatment facilities and community-based drug and alcohol prevention programs. The drug is pure hydrocodone and is not in an abuse-deterrent formulation.
Healthcare professionals are not alone in their opposition: 28 attorneys general fired off a letter in December asking the FDA to change its mind or at least fast-track a requirement for the drugmaker to create an abuse-resistant version of the drug.
“We believe your approval of Zohydro ER has the potential to exacerbate our nation's prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly five to 10 times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties,” the attorneys general wrote.
Concern also preceded the regulator's approval, with an advisory panel voting 11-2 against a regulatory green light.
“In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous high-dose opioid,” FedUp! wrote in its February 24 petition.