After last week expressing her opinion that Massachusetts Governor Deval Patrick was "out of line" with his move to block controversial superstrength painkiller Zohydro, U.S. District Court Judge Rya Zobel granted maker Zogenix's request for an injunction temporarily halting the ban.
After Massachusetts Gov. Deval Patrick banned Zogenix's powerful new FDA-approved painkiller, Zohydro, the company filed a lawsuit arguing the ban was unconstitutional. On Tuesday, federal district court judge Rya Zobel said she was inclined to agree with Zogenix and was leaning towards granting a preliminary injunction that would allow Zohydro to be sold in Massachusetts.
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 filed a lawsuit in a Boston federal court seeking a restraining order against the governor's Zohydro ban.
In the wake of the controversy over the FDA's decision to approve Zohydro, a pure hydrocodone drug that has no tamper-resistant technology tied to it, FDA Commissioner Margaret Hamburg Thursday used the approval of a new overdose treatment that anyone can carry to make her case that the FDA is just as concerned as everyone else about opioid drug abuse in the country.
While congressional reps and activists flog the FDA for approving the powerful new painkiller Zohydro, Massachusetts Gov. Deval Patrick is taking a more direct approach. Patrick says he's banning Zohydro from his state until Zogenix develops an abuse-deterrent version.
As pharmacies began dispensing Zogenix's powerful new painkiller Zohydro this week, FDA Commissioner Margaret Hamburg found herself under increasing pressure to revoke her agency's approval of the drug and yank it off the market. But she's not about to cave in to the pressure, she told the U.S. Senate's Health, Education, Labor and Pensions Committee during a hearing on Thursday, according to Reuters.
As the commercial release of Zogenix's hydrocodone bitartrate pain drug Zohydro spawns headlines from coast-to-coast warning of a potential epidemic of abuse similar to what was seen with OxyContin, the rival Purdue Pharma says it has successfully wrapped a Phase III trial of its abuse-resistant competitor. And the data sets the stage for an FDA filing later this year as Zogenix labors at its own early-stage efforts at making a pain pill that's harder to abuse.
No such thing as bad publicity? Zogenix might disagree. Preparing to roll out its powerful new painkiller, Zohydro, the company faces an outcry about its addictive potential. So, Zogenix is scrambling to defend itself and the drug, with promises of a tempered, careful launch.
With its potential for addiction and its lack of abuse-deterrent features, Zogenix's Zohydro painkiller had its critics even before its regulatory green light in October. Now, with the powerful product on the market, a coalition of activists is taking its protest to the next level.
The FDA approved a powerful new painkiller from Zogenix despite opposition from its own advisory panel. Now, attorneys general from 28 states have jumped in to ask the agency to reconsider.