Federal judge blocks Massachusetts’ Zohydro ban

April 16, 2014

A federal judge has blocked Massachusetts’ attempt to ban the controversial new painkiller Zohydro ER, which law enforcement officials, politicians, and some healthcare officials fear will dramatically increase opioid overdose deaths.

A federal judge has blocked Massachusetts’ attempt to ban the controversial new painkiller Zohydro ER, which law enforcement officials, politicians, and some healthcare officials fear will dramatically increase opioid overdose deaths.

Last month, Gov. Deval Patrick issued an executive order banning the sale of Zohydro "until determined that adequate measures are in place to safeguard against the potential for diversion, overdose, and misuse." 

Zogenix, the makers of Zohydro, filed a lawsuit in federal court in Boston to lift the ban. The company argued that Massachusetts ban overstepped federal law. U.S. District Court Judge Rya Zobel agreed, and on Tuesday issued a preliminary injunction.

"When the Commonwealth interposed its own conclusion about Zohydro ER's safety and effectiveness by virtue of the emergency order, did it obstruct FDA's Congressionally-given charge? I conclude that it did," Zobel wrote in her decision.

Judge Zobel ruled that the state’s ban would undermine the FDA's ability to make drugs available. FDA approved Zohydro ER (hydrocodone bitartrate) for chronic pain treatment and it became available in March. 

 

Zobel ruled that the legitimate use of Zohydro outweighs the state’s concerns. “Although the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers," she wrote.

 Roger Hawley, chief executive officer of Zogenix, called the decision a “positive step” for patients.

"We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment," Hawley said.

Gov. Patrick, meanwhile, expressed his disappointment with the ruling. "Addiction is a serious enough problem already in Massachusetts without having to deal with another addictive narcotic painkiller sold in a form that isn't tamper proof," Patrick said. "We will turn our attention now to other means to address this public health crisis."

Zohydro contains 10 times more hydrocodone than Vicodin. It was approved last year despite a FDA panel voting overwhelmingly against approving the drug. 

 

Fearing more drug overdoses, a coalition of doctors, addiction experts, and law enforcement officials has urged FDA to revoke approval of the powerful opioid. Additionally, Sen. Joe Manchin, D-W.Va., and Rep. Stephen Lynch, D-Mass., have introduced legislation to force FDA to withdraw the drug.  Zogenix has started an external safe-use board to provide insight and advice to the company about the impact of Zohydro on the community.