FDA Approves Powerful Hydrocodone Painkiller
FDA Tightens Painkiller Regulations While Approving Drug Ripe for Abuse
In moves that appear at odds, the FDA advocated for tightening the regulations on some painkillers in the same week that it approved a very strong new drug, Zohydro ER.
By Susan E. Matthews
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MONDAY, October 28, 2013 —The Food and Drug Administration came under a storm of media fire due to its seemingly contradictory rulings last week — one tightening regulations for painkillers, and the other approving a drug, Zohydro ER, a long-acting opioid that can easily be abused because it's not formulated to deter abuse.
On Thursday, October 25, the FDA drew praise for recommending that prescription painkillers that combine hydrocodone with other drugs, such as acetaminophen, the active ingredient in Tylenol, be moved from carrying a Schedule III label to a Schedule II label.
That would mean that this type of drug, which includes Vicodin, would be more difficult for patients to access.
For example, the new classification would mean that patients must visit a doctor every three months rather than every six months to continue getting refills. They would also have to bring the prescription to the pharmacies themselves, rather than doctors calling them in.
The FDA’s advisory panel voted 19-10 in favor of the move. The effort was seen as a strong stance in the fight against prescription painkiller abuse, which affects one in five Americans, according to the U.S. National Institutes of Health.
But the next day, the FDA approved a painkiller Zohydro ER against the advice of its own advisory panel, which voted 11-2 against. The drug is a narcotic painkiller that critics worry has a high potential for abuse, since it's the first hydrocodone-only opioid, making the drug much closer to heroin.
“The approval of Zohydro ER is distinct and separate from the agency’s recommendation about whether hydrocodone-containing combination products should be rescheduled,” Morgan Liscinsky, an FDA press officer wrote in an email. Liscinsky added that Zohydro ER would have been a Schedule II controlled substance regardless of the agency’s recommendation for hydrocodone-combination drugs, he added.
“Many people in the addiction community were shocked and disappointed,” said Caleb Alexander, MD, MS, co-director of the center for drug safety and effectiveness at the Johns Hopkins Bloomberg School of Public Health. “I think the real question here is ‘is there a compelling need for this drug?’”
Unfortunately, the FDA doesn’t consider the need for a new drug in the approval process, Dr. Alexander said. “I’ve never seen the FDA decline to approve solely because there are alternatives available,” he said.
The drug will not be formulated to prevent abuse, as OxyContin, also a Schedule II drug and previously one of the most abused prescription drugs, has been. The form of Zohydro that has been approved can easily be crushed so the drug’s potential can be absorbed more quickly.
“We consider the development of opioid analgesics with abuse-deterrent properties to be a public health priority and are actively supporting product development in this area,” Liscinsky said. However, the new ways of formulating drugs to prevent abuse is “still in its early stages and abuse-deterrent formulations are not available for most ER/LA analgesics,” he wrote.
The company that makes Zohydro, Zogenix, plans to develop an abuse-deterrant formula, the company said in a statement to MedPage Today. A report from MedPage today published earlier this month suggests that during the clinical trials on Zohydro, a process called the “enriched enrollment methodology” was used, meaning that the drug companies were allowed to remove people who didn’t respond well to the drug before officially beginning the trial.
The recommendation to reclassify the combination pain killers would still have to be approved by the U.S. Department of Health and Human Services, and then be adopted by the Drug Enforcement Agency before it becomes law.
Video: How new regulations on the popular painkiller
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