Vicodin and other hydrocodone- combination painkillers may face tighter U.S. oversight following repeated reports of misuse and addiction that have been cited by the Drug Enforcement Administration.
Advisers to the Food and Drug Administration, which regulates pharmaceutical sales, will meet in October to discuss the risks and benefits of hydrocodone preparations used as pain relievers or cough suppressants, the agency said in a notice today on its website. The DEA has been taking a closer look at rules for hydrocodone combinations since 1999.
Prescription pain relievers are the second-most abused drug in the U.S. after marijuana, with hydrocodone-related emergency room visits more than doubling from 2004 to 2010, according to the Substance Abuse and Mental Health Services Administration. Consumers have easier access to hydrocodone through combination drugs, such as the acetaminophen-mixed Vicodin, which have fewer regulations than pure hydrocodone.
The DEA is seeking to change the drug classification in a way that would require more interaction with doctors in order for people to obtain those combination products.
“It has to do with penalties for trafficking,” Barbara Carreno, a spokeswoman for the enforcement agency, said in a telephone interview. “You have to go back to the doctor when you run out of medicine. It’s more oversight by the doctor.”
If the FDA determines in October that the medicines should have more oversight, the DEA will act to change its schedule classification to match, Carreno said.
A change in such classification may benefit companies including Zogenix Inc. (ZGNX), which is developing a pure form of hydrocodone that would have to compete with less controlled substances such as Abbott Laboratories (ABT)’ Vicodin and the generic equivalents. Zogenix rose 3.8 percent to $1.93 at the close of New York trading.
Zogenix submitted an application to the FDA for its product, Zohydro, in May. The San Diego-based company has said Zohydro doesn’t contain acetaminophen, which avoids the potential for liver injury.
“We already understood that Zohydro will be regulated as a DEA Schedule II product versus the currently marketed hydrocodone combination products which are all Schedule III,” Catherine O’Connor, a Zogenix spokeswoman said in an e-mail. “We are supportive of measures to help with the responsible prescribing of hydrocodone and other opioid products.”
Hydrocodone is an opioid considered by the DEA to be a Schedule II controlled substance, the second-highest level on a five-stage scale that takes into account the potential for addiction. Hydrocodone combinations are one class lower and as a result have fewer restrictions on sales.
The DEA asked the FDA to review rescheduling hydrocodone in 2004, Morgan Liscinsky, an FDA spokeswoman, said in an e-mail. The FDA responded in 2008 and didn’t make its response public. The DEA asked again for a review in 2009, she said.
Senate legislation, S. 3187, passed May 24 that allows the FDA to collect $6.4 billion in review fees includes a provision to restrict access to hydrocodone products. A version passed by the House of Representatives, H.R. 5156, doesn’t contain hydrocodone language. The two chambers are working out the differences in the bills they must pass before the current user fee programs expire Sept. 30.
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