The maker of the controversial painkiller Zohydro is seeking federal approval of a harder-to-abuse version, but its lawsuit against the state is "ongoing," even though a judge struck down Massachusetts' ban of the drug and some of the subsequent restrictions the state put on it.
San Diego-based Zogenix said it has submitted a supplemental application to the Food and Drug Administration for a new form of Zohydro extended-release capsules that is more difficult to snort or inject. If it is approved, as the company expects, in the first quarter of 2015, the drugmaker would replace the current version of Zohydro in the second quarter.
The company still, however, is challenging U.S. District Judge Rya W. Zobel's July 8 decision upholding a state Board of Registration in Pharmacy regulation requiring that only pharmacists handle Zohydro in a drug store.
"That legal action is ongoing in federal court, and the company will provide additional updates as it moves through the process," Zogenix said yesterday in a statement.
A hearing on the company's complaint is expected in December.
"Our office has urged the FDA as well as manufacturers to make abuse-resistant and tamper-resistant formulations of their drugs, especially potent opioids," Christopher Loh, a spokesman for Attorney General Martha Coakley, said in a statement yesterday. "That continues to be an important tool in the fight against abuse and a minimum safeguard that should be employed by manufacturers of painkillers."
The FDA approved Zohydro last October. But in late March, Gov. Deval Patrick declared a public health emergency because of a growing number of opiate overdoses and banned the prescription and sale of hydrocone-only drugs, of which Zohydro is the only one.
The company sued, arguing that it was being singled out unfairly, and in April, Zobel lifted the ban. Within days, the boards of registration in medicine and pharmacy and the Board of Registration of Physicians Assistants passed regulations placing restrictions on how the drug could be prescribed and sold.
In July, Zobel struck down a requirement that doctors or physicians assistants certify in a "letter of medical necessity" that "other pain management treatments have failed" for a patient who has been prescribed Zohydro.
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