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

Illustration from PainAndDepression.com

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.

New form of Oxy is harder to inhale and inject, so drug users are turning to heroin, Opana for high

A new formulation of OxyContin makes it harder to
inhale or inject. Drug Enforcement Administration photo.

A change in the formulation of the powerful drug OxyContin has addicts turning to another high to fuel their habit: heroin.

Researchers at the Washington University School of Medicine in St. Louis had more than 2,500 patients from 150 drug rehabilitation treatment centers in 39 states respond to survey questions that had a particular focus on the reformulation of OxyContin, reports research-reporting service Newswise. The new formula makes it harder to crush the pills, making inhaling or injecting them more difficult.

Since the new version of the drug was introduced, "inhalation or intravenous administration has dropped significantly," said lead investigator Theodore J. Cicero. But drug use has not lessened, with addicts turning to heroin instead, which is also inhaled or injected. "We're now seeing reports from across the country of large quantities of heroin appearing in suburbs and rural areas," Cicero said.

OxyContin was originally designed to be released in the body slowly, preventing an immediate high. But by crushing the pills and inhaling them or dissolving them in water and then injecting the solution, addicts were able to get "an immediate rush," Newswise reports.

Moreover, because OxyContin was designed to be slow-release, it contained large amounts of the generic drug oxycodone, which spurred even more in demand. The new version of the drug was introduced in 2010.

Survey results show "users who selected OxyContin as their primary drug of abuse has decreased from 35.6 percent of respondents before the release of the abuse-deterrant formulation to 12.8 percent now," Newswise reports. (Read more)

The Centers for Disease Control and Prevention has called prescription drug abuse an "epidemic." In Kentucky, about a 1,000 people die each year from prescription drug overdoses. More people die in Kentucky from prescription drug overdoses than they do from traffic accidents.

Law enforcement is also seeing that drug seekers are switching from OxyContin to the prescription drug Opana, reports Donna Leinwand Leger for USA Today. "A few years ago, it was OxyContin. Now it's Opana," said Raquel Foster, a police spokeswoman for the Fort Wayne Police Department.

As a new, harder-to-abuse formulation of Opana hits the market, however, "they are going to find a way to satisfy their addiction," said DEA Special Agent Gary Boggs of the Office of Diversion Control. "When they either can't get those particular pharmaceuticals or can't afford them, they now gravitate to heroin."  (Read more)