Zogenix knows it needs to step on the gas. If the company doesn't develop an abuse-resistant version of its controversial-and-powerful painkiller Zohydro--and quickly--another drugmaker will speed past.
Zogenix knows it needs to step on the gas. If the company doesn't develop an abuse-resistant version of its controversial-and-powerful painkiller Zohydro--and quickly--another drugmaker will speed past. And that could put Zohydro out of the race completely.
Zogenix is facing some staunch opposition to its powerful new pain drug, Zohydro. Soon it could be facing some serious competition as well.
Teva announced that its abuse-resistant version of extended-release hydrocodone--the opioid CEP-33237--aced a pivotal Phase III. Unsurprisingly, the pain drug beat out a placebo in the chronic back pain study, which sets the stage for a new drug application for later in the year. Purdue Pharma, meanwhile, has already raced to the FDA with its own tamper-resistant version of hydrocodone.
Zogenix is selling its Sumavel DosePro Needle-free Delivery System for migraines to Endo International, but don't be fooled--it is maintaining ownership of the delivery technology upon which the product is based.
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.