As drugmakers race to develop more and more powerful painkillers, the federal government is stepping in to try and prevent addicts from getting easy access to the products. On Thursday, the Drug Enforcement Agency (DEA) announced that combination drugs containing hydrocodone will now be classified as Schedule II products, imposing on them the same restrictions that apply to pure hydrocodone, as well as oxycodone and morphine.
The new rule will make it more challenging for patients to gain access to products such as AbbVie's ($ABBV) Vicodin, which is a blend of hydrocodone and acetaminophen. Patients will have to show up at pharmacies with written prescriptions--no more call-ins from physicians, in other words. And they will not be granted as many automatic refills.
Vicodin and similar products used to be grouped in the less restrictive Schedule III, but recent DEA research showed that the drugs can be as addictive as pure opioids and "may lead to severe psychological or physical dependence," a statement from the agency says. "Adding nonnarcotic substances like acetaminophen to hydrocodone does not diminish its abuse potential."
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| Michele Leonhart |
DEA Administrator Michele Leonhart pointed out in the statement that nearly 7 million people in the U.S. abuse prescription drugs such as painkillers and there are more deaths from prescription drug overdoses than there are from car accidents. "Today's action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available," she said.
The DEA's move comes after months of criticism, aimed mostly at the FDA, over the approval of powerful painkillers that many fear have high abuse potential. Most recently, the FDA has come under fire for approving Zogenix's ($ZGNX) pure-hydrocodone pill Zohydro. The pill doesn't come with abuse-deterring features, causing an uproar and prompting several state and federal efforts to get the drug pulled from the market.
Last year, the FDA heard testimony on the question of whether it should take hydrocodone combination drugs more seriously, and it released guidance for makers of all types of opioid painkillers urging them to develop technologies for preventing abuse. Still, FDA Commissioner Margaret Hamburg continues to defend the agency's approval of Zohydro on the grounds that doctors and patients need as many options as possible for managing chronic pain.
All the controversy certainly isn't discouraging the pharma industry from coming up with new pain meds. Teva's ($TEVA) abuse-resistant version of extended-release hydrocodone aced a Phase III study in May and the company is now preparing for its FDA filing. Pfizer ($PFE) and Purdue Pharma are also in the late stages of developing next-gen pain remedies.
- here's the DEA's statement
- read more at Reuters