San Diego-based Zogenix Inc announced on Tuesday it would sell its Zohydro business to Pernix Therapeutics Holdings in a deal that could be worth nearly $400 million.
Zohydro ER is the first and only extended-release hydrocodone without acetaminophen approved by the U.S. FDA for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Several industry groups have petitioned the FDA to revoke approval of the controversial drug, citing concerns about the drug's potency and abuse potential. Last March, FDA Commissioner Dr. Margaret Hamburg defended the approval of the painkiller to a Senate panel, claiming the benefits of the drug outweigh the risk.
The Pernix acquisition includes three extended release hydrocodone products, including an abuse-deterrent pipeline and all related intellectual property. Zogenix, in turn, will receive a $100 million upfront payment and as much as $283.5 million in milestone payments,