This week, the U.S. Food and Drug Administration is set to conduct a two-day hearing on whether hydrocodone products such as Vicodin should be more highly regulated like other narcotics like OxyContin and morphine, this article reports. FDA researchers said in recent briefing documents that while chronic pain patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction, the article says. But critics say hydrocodone is potent and highly addictive, and that updating the drug’s classification could help bring the prescription drug addiction epidemic under control, according to the article.
Last year, pharmacy interest groups defeated an amendment to the FDA Safety Innovation Act that aimed to change the classification of hydrocodone-containing pain relief products from Schedule III to the more-restrictive Schedule II.
Combination hydrocodone products such as Vicodin and Norco are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.
The amendment to the Prescription Drug User Fee Act (PDUFA) re-authorization bill would have rescheduled hydrocodone from Schedule III to Schedule II, putting hydrocodone painkillers into the same category as OxyContin and Percocet. Hydrocodone is the most-prescribed prescription drug in the U.S., with 131.2 million prescriptions written in 2010 alone.
Pharmacy organizations had fought the amendment, saying it will keep such medications out of the hands of patients who need them and increase health care costs.
Separately last month, an FDA panel voted against the agency approving Zogenix Inc.’s Zohydro painkiller, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin. In an 11-2 vote, the advisory panel said Zogenix had met FDA standards for safety and efficacy, but cited concerns about the danger of addiction posed by the opioid drug class, according to this article.
The FDA could still approve the drug for sale in the United States by imposing restrictions to protect public safety, though it usually follows the advice of its advisory panels when deciding whether to approve new medicines. Agency officials will consider the committee’s recommendation in deciding by March 1 whether to give Zohydro the green light.
San Diego-based Zogenix Inc.’s bid for FDA approval to begin marketing Zohydro has prompted some activists to appeal to the agency not to rubber-stamp more opioid drugs in the midst of an out-of-control epidemic. Proponents of extended-release versions of opioids – such as Purdue Pharma’s recently reformulated OxyContin, OP – claim the drugs are safer because they are “abuse-resistant,” but others point out that many opioid-addicted people simply swallow the pills whole. (Addicts are also already finding their way around allegedly tamper-proof versions.)
Other pharmaceutical companies – including OxyContin maker Purdue Pharma – are already working on their own versions of Zohydro.