The Food and Drug Administration has notified Zogenix Inc. (NASDAQ: ZGNX) that it will soon make a final decision on the company’s powerful new painkiller, Zohydro.
In a statement, the San Diego-based company said an FDA action letter on the New Drug Application (NDA) for Zohydro could be made “after a further delay of short duration.”
The FDA had previously said an action letter would be released this summer. Not only did the agency fail to meet that timetable, but it could now encounter further delays due to the government shutdown over the Affordable Care Act.
“Zogenix and the FDA have completed the final labeling and reached agreement on the post-marketing requirements for Zohydro ER. The FDA has also reconfirmed there are no deficiencies in the NDA. While the FDA indicated its intent to take prompt action on the Zohydro ER NDA, the timing for a decision may be impacted by the current federal government shutdown,” the company said.
If approved, Zohydro would be the first pure hydrocodone painkiller sold in the U.S. Combination versions of hydrocodone, such as Vicodin, typically contain acetaminophen and require dosing every 4 to 6 hours. Extended release Zohydro could be taken just twice a day.
Late last year a panel of pain experts advised the FDA to reject Zohydro because of potential abuse of the opioid painkiller. The vote was 11-2 with one abstention.
“If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” FDA staff reviewers wrote in a report.
The FDA is not obligated to accept the findings of its advisory committees or staff.
Zogenix maintains that Zohydro would be a safer formulation of hydrocodone because it does not contain acetaminophen. The use of drugs containing acetaminophen in high doses raises the risk of liver injury. Acetaminophen overdose is a leading cause of acute liver failure in the United States, with nearly two out of every three acetaminophen overdoses attributed to hydrocodone-acetaminophen products.
If approved, Zohydro would be classified as a Schedule II drug, making it subject to stricter prescribing and dispensing rules. All hydrocodone products are currently classified as Schedule III drugs, although the FDA is considering the reclassification of hydrocodone as a Schedule II controlled substance.