Congressional Bills Seek Ban on FDA-Approved Zohydro

Legislation in both the US House of Representatives and the Senate seeks to reverse the FDA's recent approval of Zogenix's hydrocodone-only painkiller Zohydro, because the drug's formulation does not include an abuse deterrent.

Recently introduced legislation in both the US House of Representatives and the Senate seeks to reverse the FDA’s recent approval of Zogenix’s hydrocodone-only painkiller Zohydro, because the drug’s formulation does not include an abuse deterrent. The bills also seek to prevent approval of future formulations of opioids like Zohydro that do not have abuse-deterrence elements.

Zohydro has been the subject of complaints from members of Congress and advocacy groups, all asserting that Zohydro is dangerous and should not have been approved. The FDA Commissioner has defended the agency’s approval of the medication.

“Unless this product is reformulated to prevent abuse, I strongly believe Zohydro will only fuel addiction and death in this nation,” Sen. Joe Manchin, D-WV, who introduced the bill in the Senate, said in a statement. “It must be kept off the market for the well-being of our nation, especially our families and our youth.”

Congressmen Stephen Lynch, D-MA, and Hal Rogers,R-KY, introduced the House bill, the Act to Ban Zohydro, on the same day.

A press release from Purdue Pharma, maker of OxyContin, said the company will be filing a New Drug Application later this year for its hydrocodone-only opioid, now in Phase III trials. The formulation will include abuse-deterrent properties. It remains to be seen how the possible approval of this investigational Purdue opioid affects the controversy over Zohydro.

Purdue conducted a series of studies with the medication and the abuse-deterrent properties are intended to make the tablets difficult to manipulate for the purpose of misuse and abuse.

“We are very encouraged by the results of this pivotal study,” Gary L. Stiles, MD, Purdue Pharma’s Senior Vice President of Research and Development, said in a statement. “This is another step forward in our efforts to develop therapeutic options for use by chronic pain patients that are designed to be unattractive to drug seekers.”