Going against the recommendation of its own panel of outside advisers, the U.S. Food and Drug Administration, or FDA, has approved a powerful, pure hydrocodone painkiller that lacks features to deter abuse.
Law enforcement agencies and drug-addiction experts say the new opioid pain pill, Zohydro ER, will likely create more addicts and cause overdose deaths to increase. Zohydro will be the first pure hydrocodone medication available in the United States. It is expected to reach the market early next year.
Current forms of the medication, such as Vicodin, are combined with weaker painkillers like acetaminophen. Because of its purity, Zohydro is potentially 10 times stronger when abused than any version of hydrocodone medication currently available, experts say.
Hydrocodone belongs to the opioid family of medications, a highly addictive group of drugs that includes morphine, codeine, methadone and oxycodone, which officials say is one of the most abused and deadly drugs.
Opioid pain pills designed to release a drug over time, such as Zohydro, are often crushed and snorted by addicts seeking a stronger, immediate high, law enforcement officials have said. Purdue Pharma, the company that makes OxyContin, introduced a tamper-resistant form of the pill in 2010, making it harder to crush or dissolve, and experts say that has helped cut down on abuse
Zohydro does not include such features at present.
Zogenix, the company that makes Zohydro, has “started the development of an abuse deterrent formulation of Zohydro ER, and we are committed to advancing the program as rapidly as possible,” the company’s president, Stephen Farr, said in a statement.
“That the FDA has approved another incredibly powerful painkiller without (tamper-proof features) is both disconcerting and dangerous,” said Jeffrey Reynolds, the executive director of the Long Island, N.Y., Council on Alcoholism and Drug Dependence, who testified before the expert panel in opposition to Zohydro’s approval without safety features. “While this drug might be a godsend for people with acute pain, it’s a potential nightmare for those struggling with or at risk for addiction.”
An FDA advisory panel of experts voted 11-2 in December 2012 against approval of Zohydro because of concerns it would be abused. But the FDA is not bound by advisory opinions and has gone against panel decisions before.
The FDA said Zohydro should be prescribed only for the management of pain severe enough to require daily, round-the-clock, long-term treatment and for which alternative treatment options are inadequate.
“Due to the risks of addiction, abuse and misuse with opioids ... Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain,” the FDA said in a statement.
The FDA does not require abuse-deterrent formulations of opioids at present. But critics of Zohydro’s approval say the agency should have waited until that formulation was ready.
“It’s hard to believe that in the midst of an epidemic of opioid addiction and overdose deaths caused by opioid overprescribing that FDA would approve a new, easily chewable opioid that packs in a whopping dose of hydrocodone,” said Dr. Andrew Kolodny, the president of the national advocacy group Physicians for Responsible Opioid Prescribing, which presented its case against Zohydro to the FDA advisory panel. “A single pill can be lethal for someone not used to taking opioids.”