Ever since the FDA approved Zogenix's all-hydrocodone painkiller Zohydro last year, both the agency and the company have faced a storm of criticism. The powerful pill, without tamper-resistant features, was destined to be abused, they claimed.
The FDA approved opioid painkiller Zohydro nearly a year ago as a med to provide relief for those with chronic pain. But the drug has been nothing but 11 months of aggravation for the agency and its leader, Commissioner Margaret Hamburg, who is now being called on to resign by organized anti-addiction groups who say the FDA has contributed to an epidemic of abuse in the country.
Count five U.S. governors among the lobbyists for a turnabout on the powerful painkiller Zohydro. The New England politicians wrote Health and Human Services Secretary Sylvia Burwell last week, urging her to yank the drug's FDA approval.
Marketing can be a bit like dating. If you're not getting results with one target, then it's best to focus on someone else. That's exactly what Zogenix is doing, by tweaking its Zohydro launch strategy.
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.