Attorneys general from 29 states have asked the Food and Drug Administration to reconsider its recent approval of Zohydro, a powerful new extended release painkiller.
In a letter sent to FDA Commissioner Margaret Hamburg, the attorneys general said they did not want a repeat of the past when narcotic painkillers entered the market without tamper resistant formulas. Drug abusers learned they could crush or liquefy painkillers such as oxycodone to snort or inject the drug.
“We believe your approval of Zohydro ER has the potential to exacerbate our nation’s prescription drug abuse epidemic because this drug will be the first hydrocodone only opioid narcotic that is reportedly five to ten times more potent than traditional hydrocodone products, and it has no abuse deterrent properties,” the letter says.
In October, the FDA ignored the advice of its own advisory panel, which voted to reject Zohydro because of its potential for abuse.
“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, which is not required to follow the recommendations of its advisory committees, did not require that Zohydro be made with a tamper resistant formula.
“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, with no refills allowed. There are also more stringent recordkeeping, reporting, and security requirements for Schedule II drugs. In October, the FDA recommended reclassifying all hydrocodone products as Schedule II drugs.
Hydrocodone products such as Vicodin typically contain acetaminophen, which is a leading cause of liver failure in the U.S. Nearly two out of every three acetaminophen overdoses are attributed to hydrocodone-acetaminophen products. Vicodin is the most prescribed medication in the U.S.
Zogenix (NASDAQ: ZGNX), the San Diego based company that makes Zohydro, claims its new drug will actually be a safer formulation of hydrocodone because it does not contain acetaminophen.
The company says it is developing an abuse deterrent formula for Zohydro and was “committed to advancing the program as rapidly as possible.” In February, the company said it was “a few years” away from developing such a formula.
In their letter, the attorneys general said they wanted the FDA to set a “rigorous time line” for Zohydro to be reformulated.
“The approval of this very potent drug is troubling because, unlike extended-release opioids containing abuse-deterrent properties, there is nothing that would prevent someone from easily crushing or injecting Zohydro ER to get high,” said Kentucky Attorney General Jack Conway.
“For decades, we have fought the disastrous effects of the illegal marketing of the drug OxyContin. Zohydro ER has the potential to exacerbate the prescription pill epidemic and given that abuse-deterrent properties are capable of being developed and required, the FDA’s decision to approve the drug doesn’t make sense.”
Purdue Pharma reformulated OxyContin in 2010 to make it more resistant to tampering.Tags: FDA, Zogenix, Zohydro