Updated: Controversial opioid Zohydro ER pulled from the market
As the Belgian pharma UCB recently inked a $1.9 billion deal to buy out Zogenix and its top drug for epilepsy, the company’s former controversial opioid has now been pulled from the market, according to a Federal Register filing by the FDA on Tuesday.
Hydrocodone-based Zohydro ER — which initially won FDA approval in 2013 despite not having abuse-deterrent properties and despite an 11-2 adcomm vote against approval — is now one of 29 new drug applications from multiple sponsors that have decided to pull their drugs from the market for various reasons, according to the filing.
The filing to pull Zohydro was made by Zogenix’s Georgia-based contract manufacturer Recro Gainesville. In 2015, Zogenix sold Zohydro ER to Pernix Therapeutics for $100 million plus regulatory and sales milestones up to $284 million. In 2019, Pernix was sold to Tennessee-based Currax Pharmaceuticals, which is who most recently distributed the drug. The Zohydro NDA was then sold to Persian Pharmaceuticals LLC in 2019, and later transferred to Recro Gainesville in mid-2021.
Back in 2014, Zohydro made headlines as Massachusetts banned the prescription, ordering, dispensing, and administration of the new opioid, but then had that ban overturned in court, with Zogenix arguing that the ban was preempted by federal law.
“If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health,” the federal court said in its decision.
The FDA also came under fire for the approval and went to great lengths to try to defend the opioid, as well as to correct misinformation around the drug’s strength, which is something the agency rarely does.
“It is misleading to say that Zohydro ER is stronger than anything currently on the market,” the agency said in 2014. “While Zohydro ER has a higher available strength compared to immediate-release products with the same active ingredient, Zohydro ER can deliver the same amount of medication per day with fewer doses (e.g., two doses of Zohydro ER compared to 4 to 6 doses for immediate-release products with the same active ingredient).”
Article updated to note additional sales of Zohydro ER.
