San Diego-based Zogenix (NYSE:ZGNX) has filed a lawsuit in federal court in Boston seeking a temporary restraining order to prevent Massachusetts Governor Deval Patrick from implementing a ban on the prescribing and dispensing of Zohydro, the company’s controversial new painkiller.
The suit claims that an executive order issued by Patrick is in “direct conflict” with the authority of the Food and Drug Administration to determine whether a drug is safe and effective. The FDA approved Zohydro – the first pure hydrocodone painkiller — over the objections of its own advisory committee, which warned that Zohydro could be abused even more than currently available hydrocodone products. Zogenix said a request to meet with the governor to discuss the issue went unanswered.
“Governor Patrick’s unilateral action was taken without any communication or advanced notice. In very limited interactions with his staff after the decision, we are convinced the decision was driven by factual inaccuracies about the science and the data. Unfortunately, it left us little recourse but to put the needs of patients in severe chronic pain ahead of politics and file for an injunction to stop the executive order,” said Roger Hawley, CEO of Zogenix.
“Zohydro was approved by the FDA after an exhaustive 18-month review of the clinical trial data. This rigorous FDA review process serves the nation’s public health needs, the medical community and those in severe chronic pain, and the FDA regulatory authority simply should not be usurped by individual states.”
The FDA is under growing political pressure to reverse its decision. Bills have been introduced in Congress to force the FDA to withdraw its approval of Zohydro.
Update: Mass Live is reporting that a hearing on the Zogenix lawsuit has been scheduled for Monday, April 14 before U.S. District Court Judge Rya Zobel. Judge Zobel said she is skeptical of Gov. Patrick’s authority to ban a drug that has been approved by the FDA. “At the moment, I think that, frankly, the governor is out of line on this,” Zobel said.
Gov. Patrick declared a public health emergency last month over the “growing opioid addiction epidemic” and ordered the unprecedented ban on Zohydro. Some addiction treatment experts have claimed that Zohydro – which came on the market just a few weeks ago – will fuel a new wave of narcotic abuse and overdoses.
“The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large,” the Governor’s office said in a statement.
Zogenix claims Zohydro is actually safer than other hydrocodone combination products, such as Vicodin, because it does not contain acetaminophen – which can cause liver damage at high doses.
“For those patients in Massachusetts struggling every day with severe chronic pain who are tolerating immediate-release hydrocodone therapies which contain acetaminophen, having a new option of hydrocodone could provide a significant benefit,” the company said. Unlike Vicodin and other hydrocodone products – which require doses every few hours — extended release Zohydro is designed to be taken just twice a day.