Latest Headlines

Latest Headlines

FDA releases guidance on abuse-deterrent opioid formulations

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 figures 1 + 1 + 1 equals more than three with new Zohydro salesforce

Pernix Therapeutics is looking for a sales trifecta from the 100 new Zohydro reps it's acquiring along with that pain drug franchise.

Pernix looks for a sales trifecta from 100 new Zohydro reps

Why buy a controversial pain drug franchise that's up against some hefty competition? Pernix Therapeutics has one word for you: synergies.

Zohydro changes hands as Zogenix sells to Pernix for $100M-plus

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 jettisons controversial pain med Zohydro for $100M-plus

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.

FDA approves tamper-resistant reformulation of Zohydro in continuing battle against opioid abuse

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.

New Zohydro formula gets FDA's blessing, but abuse-deterrent label has to wait

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.

Zogenix races to FDA with abuse-deterrent version of maligned pain pill Zohydro

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.

Hamburg called on to resign for FDA's approval of Zohydro

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.

Governors to HHS secretary: Nix that FDA nod for controversial painkiller Zohydro

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.