Sens. Patrick Leahy (D-Vt.) and Richard Blumenthal (D-Conn.) called on the Food and Drug Administration (FDA) Monday to expedite its review of a major painkiller’s anti-abuse properties.
Zogenix’s Zohydro ER is an extended release version of the first approved pure hydrocodone product. Despite widespread criticism of the drug's abuse potential, the FDA argues it is needed to help patients with severe pain and reduce their risk of liver toxicity from hydrocodone combination products.
“The drug was approved despite lacking any abuse-deterrent properties and over strong objections from the FDA’s own independent advisory committee,” the senators wrote. “We share the concerns of the many governors and state attorneys general who believe this powerful drug is all but certain to exacerbate our nation’s addiction to opioid analgesics, which results in tens of thousands of overdose deaths each year.”
Leahy and Blumenthal demanded that the FDA brief them on plans to monitor the use of Zohydro ER and whether it will reevaluate the drug’s status if widespread problems develop.
“Given their potency and ease of abuse, we have little doubt that pure opioid products may lead more Americans to addiction, some even to heroin,” Leahy and Blumenthal wrote. “As safer, abuse-deterrent opioids are approved, the FDA should act swiftly to remove any older, less safe versions.”
The senators said they hope the FDA acts quickly because it has taken up to three years for the FDA to ban products that lack abuse-deterrent properties in the past.
During a hearing last month over the FDA’s budget, Rep. Hal Rogers (R-Ky.), chairman of the House Appropriations Committee, grilled FDA Commissioner Margaret Hamburg why the agency did not delay Zhydro’s approval until abuse deterrent versions of the drug were available. Hamburg responded by stating there was no guarantee abuse deterrent products that make the pills harder to crush or dissolve will work.
While Zogenix is suing Massachusetts for banning Zohydro the company also recently announced it was selling off its migraine injection Sumavel in order to raise capitol to develop an abuse deterrent version of the Zohydro. But that may not be enough as Purdue Pharma is already ahead of the pack with its own abuse deterrent hydrocodone under development.
— This article was updated at 4:15 p.m.