Friday, March 14, 2014

Rogers, other drug-caucus chair file bill to reverse FDA's approval of new painkiller; competing company has alternative

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U.S. Reps. Hal Rogers of Somerset and Stephen Lynch of Massachusetts have introduced a bill to withdraw federal approval of a new formulation of hydrocodone that is highly addictive and produced in crushable pills, which they say threatens to start a new wave of prescription drug abuse. They are the Republican and Democratic co-chairs, respectively, of the Congressional Caucus on Prescription Drug Abuse.

But the Food and Drug Administration might act against Zohydro ER on its own, because Purdue Pharma LP has completed testing of a competing, non-crushable drug and will ask for "a priority review that would cut two to three months off the 10 months the agency sets as a goal to examine applications" for regulatory approval, Drew Armstrong of Bloomberg News reports. "Purdue’s pill is hard to crush and snort or inject."

That is important to the FDA. “If and when they, or another manufacturer, are able to create an abuse-deterrent formulation that remains safe and effective for patients, we would certainly give serious consideration to assuring that any non-abuse formulations are removed from the market,” FDA pain-drug director Bob Rappaport said in his Oct. 25 review of Zohydro’s approval.

Zohydro ER is an extended-release hydrocodone medication made by Zogenix Inc. for patients who need round-the-clock, long-term pain treatment and have found other treatments to be inadequate. Unlike recent formulations of the popular painkillers OxyContin and Opana, is not crush-resistant, but the company has said it is working on a crush-resistant version.

Citing concerns about abuse, the FDA's scientific advisory panel voted 11-2 against approving Zohydro ER, and a coalition of more than 40 health, consumer and other organizations urged the FDA to revoke its approval. Attorney General Jack Conway was among 28 attorneys general who sent the FDA a letter asking it to reconsider. Sen. Joe Manchin, D-W.Va., has introduced a companion bill to the one filed by Rogers and Lynch.

Hal Rogers (Associated Press photo)
Rogers said in a press release, "“While the FDA continues to send mixed signals to drug companies about the need to invest in abuse deterrent technologies, the Act to Ban Zohydro will make it abundantly clear – life saving measures are critical to the development of powerful painkillers like Zohydro. . . . In Southern and Eastern Kentucky, we lost nearly an entire generation when crushable OxyContin was first prescribed, and I fear this crushable, pure hydrocodone pill will take us backwards with a new wave of addiction and tragic, untimely deaths."

Kentucky ranks third in the nation for overdose deaths, with more than 1,000 Kentuckians dying each year from prescription drug overdoses. The number has leveled off following passage of laws that target pill-pushing clinics and doctors, and put stricter regulations on painkillers.

Zogenix has said it is committed to exceeding FDA requirements to make sure the drug is used appropriately, will monitor for misuse, and will allow an outside group to monitor and analyze its data. It noted that Zohydro ER will be regulated as a Schedule II drug, which means it can only be dispensed through a physician’s written prescription, with no refills, and does not contain acetaminophen, longtime use of which can cause liver failure.

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