Zogenix Says FDA Delays Approval Decision on Painkiller
Zogenix Inc. (ZGNX) said U.S. regulators are expected to miss the scheduled March 1 decision date on the company’s effort to gain marketing approval for the first pure hydrocodone painkiller.
The Food and Drug Administration informed Zogenix that it was unlikely to reach a decision on the drug, named Zohydro, by the action date, the San Diego-based company said today in a statement. The painkiller is intended as an alternative to hydrocodone-combination treatments such as the acetaminophen- mixed Vicodin.
While regulators didn’t provide the company with a reason for the possible delay, they indicated it may last only several weeks, Zogenix said in the statement. The company said it hadn’t been informed of any deficiencies in its application.
“We are confident in the Zohydro ER program and our NDA submission and are committed to working with the FDA while it completes its review,” Stephen Farr, president and chief operating officer of Zogenix, said in the statement. “We believe there is an important medical need for an extended- release hydrocodone medicine without acetaminophen and that Zohydro ER can fill this need based on its safety and efficacy profile.”
FDA advisers said in December Zohydro shouldn’t be approved until regulators examined greater measures to curb opioid abuse.
The concern was that the painkiller doesn’t contain tamper- proof technology to deter people from crushing the capsules and snorting for a more intense effect. Zogenix, whose $38 million in 2011 revenue came from its migraine medicine Sumavel, has been counting on Zohydro to boost sales.
Zohydro uses Alkermes Plc (ALKS)’s drug delivery technology to provide extended release of the painkiller. Zogenix and Alkermes, based in Dublin, agreed Nov. 2 that Alkermes would be the exclusive manufacturer and supplier to Zogenix of Zohydro.
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