A day after saying it wanted to restrict access to hydrocodone, the Food and Drug Administration has approved a new more powerful version of the opioid painkiller that some critics say is dangerous.
Zohydro, which was developed by San Diego based Zogenix Inc. (NASDAQ: ZGNX), will 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 for chronic pain.
“Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids,” the FDA said in a statement.
Zohydro will be classified as a Schedule II drug, which means it can only be dispensed through a physician’s written prescription and no refills will be allowed. There are also more stringent recordkeeping, reporting, and security requirements for Schedule II drugs.
On Thursday, the FDA said it wanted to reclassify all hydrocodone products as Schedule II drugs because of their risk of abuse.
Zohydro ER will carry new updated labeling and stronger warnings that the FDA is requiring for all opioid pain medicines. The agency is also requiring post marketing studies of Zohydro to assess the risk for misuse, abuse, and overdose after long term use beyond 12 weeks.
However, the FDA is not requiring that Zohydro be made with a tamper resistant formula that would discourage addicts from snorting or injecting the drug.
Late last year a panel of pain experts advised the FDA to reject Zohydro because of potential abuse of the 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 to the committee.
The agency is not required to follow the recommendations of its advisory committees.
“Just as the FDA was making some steps forward in the fight to end prescription drug abuse, they take major steps back with the approval of Zohydro ER, which will now be the strongest prescription painkiller available,” said Rep. Bill Keating of Massachusetts, a longtime critic of the FDA, who is sponsoring a bill to require all brand name painkillers to have abuse-deterrent formulation.
“FDA not only approves this dangerous drug, but does so without requiring any abuse-deterrent features. This is outrageous. Abuse-deterrent technologies should not be the anomaly – they must be the norm. The technology is available and the FDA should be requiring pharmaceutical companies to employ it.”
Zogenix maintains that Zohydro would actually be safer formulation of hydrocodone because it does not contain acetaminophen, which is a leading cause of acute liver failure in the United States. Nearly two out of every three acetaminophen overdoses are attributed to hydrocodone-acetaminophen products.
“Zohydro ER fulfills a critical need among people living with chronic pain who meet the criteria for therapy with extended release opioids,” said Dr. Srinivas Nalamachu, MD, a pain specialist and investigator in clinical trials of Zohydro ER.
“A significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients.”
Zogenix said it has begun developing an abuse deterrent formulation of Zohydro ER and that it was “committed to advancing the program as rapidly as possible.”