Zogenix fights state ban on Zohydro in court

Massachusetts State House boston
The hearing is set for Tuesday afternoon.
Credit: Nicolaus Czarnecki/Metro

A federal judge hinted that she is willing to strike down the state’s ban on a painkiller at the request of the drug maker, but gave state officials more time to prepare their argument. 

The maker of Zohydro and lawyers for the state appeared in federal court Tuesday to argue the banning of the drug after Gov. Deval Patrick declared a public health emergency last month citing an “epidemic of opiate abuse.”

“The governor is out of line on this,” said Judge Rya Zobel.

Zobel gave the state until a new hearing on Monday morning to make its case after an assistant attorney general argued that her office had only received the case Tuesday morning.

Zogenix, the California-based drug maker, filed a motion in federal court on Monday that seeks to stop the state’s ban on its drug, Zohydro. A hearing was scheduled for Tuesday afternoon in federal court in South Boston.

Assistant Attorney General Jo Ann Shotwell Kaplan argued that Zogenix’s request for an injunction on the ban was not immediately necessary because no one in the state is currently using the drug.

Zobel questioned Shotwell Kaplan as to why the state didn’t contact Zogenix before the ban. Shotwell Kaplan said that the state had to act fast before people started using the drug and then would find themselves without it, which would have been dangerous.

Steven Hollman, a lawyer for Zogenix, said that so far four people in the state have been prescribed the drug, but have been unable to get it filled. He estimated thousands more would benefit from it.

“What’s the emergency here,” Hollman said in court. “The emergency is the opioids already on the market.”

Last month, citing an “epidemic of opiate abuse” in Massachusetts, Patrick declared a public health emergency. Among the steps being taken by state leaders and health officials to control the abuse was the immediate prohibition of the prescribing and dispensing of any hydrocodone-only formulation until adequate measures are in place to safeguard against potential overdose and misuse.

In court documents, Zogenix said that Zohydro is the only drug in the category targeted by the state. The company also argues that the drug, which tackles severe pain in patients requiring continuous around-the-clock opioid therapy, was approved by the Food and Drug Administration in October.

The company also argues that the ban will harm patients as well as the drug maker.

“Zogenix also stands to suffer substantial lost sales in Massachusetts as a result of the ban. It has projected millions of dollars in sales for Zohydro ER in Massachusetts in the coming years,” the company said in a court filing.

Follow Michael Naughton on Twitter @metrobosmike.



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