To prepare for a wave of opioid candidates in the pipeline, including Pfizer's abuse-deterring, extended-release opioid capsules, the FDA has finalized guidance on the evaluation and labeling of abuse-deterrent opioids.
Pernix Therapeutics is looking for a sales trifecta from the 100 new Zohydro reps it's acquiring along with that pain drug franchise.
Why buy a controversial pain drug franchise that's up against some hefty competition? Pernix Therapeutics has one word for you: synergies.
Zogenix is selling off its extended-release painkiller franchise Zohydro to New Jersey's Pernix Therapeutics for $100 million and up to $283.5 million in milestones based on sales. At one point, Zogenix looked at Zohydro as its flagship, but now it appears the company is backing away from pain management altogether.
Zogenix has taken plenty of heat over Zohydro, the all-hydrocodone painkiller that critics say is too easy for opioid addicts to abuse. But under a deal announced Tuesday, those critics will no longer be the San Diego company's concern.
The FDA approved a reformulated version of Zogenix's painkilling Zohydro ER designed to be abuse resistant, marking another step in the battle against opioid abuse and another chapter in a long-running battle over the controversial and potentially addictive medication.
Since its FDA approval, the all-hydrocodone painkiller Zohydro has sparked outrage from officials and advocates trying to fight the tsunami of opioid addiction. But with its new Zohydro formula now approved, Zogenix is hoping it can put out the fire.
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.