April 15 (Bloomberg) -- Zogenix Inc. won a federal judge’s order blocking enforcement of a ban on its painkiller Zohydro in Massachusetts, whose governor last month announced the state was facing “an epidemic of opiate abuse.”
U.S. District Judge Rya Zobel in Boston said the U.S. Food and Drug Administration, not the state, regulates the medicine for safety and noted that the agency approved it in 2013, finding it safe. She put her order on hold until April 22.
“If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health,” Zobel said in a ruling today.
Zogenyx’s drug, made of pure hydrocodone, is intended as an alternative to Vicodin and others that mix hydrocodone with less-potent medicines such as aceteminophen. Massachusetts Governor Deval Patrick issued a statement March 27 declaring a public health emergency and directing the state to take steps to deal with “an epidemic of opiate abuse.”
The declaration empowered the state’s health department to immediately prohibit Zohydro ER from being prescribed and dispensed until the agency determined that adequate measures to safeguard against diversion, overdose and misuse were in place. The company sued and asked for a court order blocking the ban.
Zohydro ER doesn’t have an “abuse-resistant formulation” and can be crushed and inhaled or injected, making the full dose of hydrocodone available immediately, Zobel said. The absence of this formulation has provoked concern that the drug may lead to addiction and overdoses, a concern especially potent given the recent spike in opioid- and heroin- related deaths in Massachusetts, she said.
The case is Zogenix v. Patrick, 14-11689, U.S. District Court, District of Massachusetts (Boston).