|Massachusetts Gov. Deval Patrick|
In late March, Massachusetts Governor Deval Patrick banned the newly approved purely hydrocodone pain pill Zohydro--and now the maker of that drug is fighting back. Zogenix ($ZGNX) filed a lawsuit in a Boston federal court seeking a restraining order against the governor's Zohydro ban. Zogenix sued after Patrick failed to respond to a request for a meeting to discuss the drug, according to Reuters.
Zohydro, the first pure opiate ever approved by the FDA, does not have abuse-deterrent features that would stop addicts from crushing it to get an immediate high. Patrick said in a release that the pill "poses a significant risk" to the public and that no pharmacy in the state would dispense it until measures were put in place to "safeguard against the potential for diversion, overdose and misuse."
In its lawsuit, Zogenix criticizes Patrick for taking "unilateral action" to ban Zohydro without giving the company any advance notice, according to Bloomberg. Furthermore, the complaint says, "When FDA approved Zohydro, it considered but rejected the idea of requiring the drug to utilize abuse-deterrent technology." Zogenix's shares have fallen 16% to $2.46 since Patrick's ban, Bloomberg notes.
|FDA Commissioner Margaret Hamburg|
The FDA has been under fire ever since it approved Zohydro last October. More than half of the states' attorneys general asked the agency to withdraw the approval, and the grassroots organization Fed Up! Coalition petitioned FDA Commissioner Margaret Hamburg to reassess the drug in late February. But she told the Senate she wouldn't back off, and that the long-acting Zohydro is a safe and effective option for patients with excruciating pain.
That's not to say the FDA isn't concerned about the opioid epidemic, Hamburg emphasized last week, after the agency approved Evzio, a single dose of naloxone that medics can use to reverse a painkiller overdose. "Tackling the opioid epidemic is a high priority for the FDA," Hamburg told the press during a briefing on the Evzio approval. The FDA also acknowledged that prescription drug overdoses are now the leading cause of injury-related deaths in the U.S., surpassing car accidents.
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