Since its release last month, Zohydro, a powerful new opioid painkiller, has sparked massive controversy in the medical community. The first extended-release form of pure hydrocodone, Zohydro contains roughly ten times the amount of the opioid found in Vicodin and numerous drug safety groups, addiction experts, and doctors have voiced concerns about this drug's potential for abuse.
"I'm not opposed to having a long-acting hydrocodone. I think its fine to have more options," says Dr. Daniel Alford, Director of the Safe and Competent Opioid Prescribing Education Program at Boston University. "What I am opposed to is the company putting this drug on the market and totally ignoring the lessons learned: that some people are going to abuse it." Zohydro was created for sufferers of chronic pain, allowing them to take only one pill every 12 hours (instead of one Vicodin every four to six) but it's only currently available as a capsule. This means it can be crushed, snorted, and relatively easily misused.
In December of 2012, the FDA advisory committee tasked with evaluating Zohydro voiced serious concerns about the drug due to its potential for abuse and misuse. While the committee agreed that the drug met the FDA's efficacy and safety standards, they voted 11-2 that it should not be approved. Still, Zohydro was approved in October of 2013. This prompted a letter from 29 state attorneys general, asking the FDA to reconsider their approval, at least until a tamper-resistant form of Zohydro exists.
Zohydro hit the market in March and states have been quick to respond. Vermont Governor Peter Shumlin announced an emergency order that requires doctors to conduct a thorough medical evaluation and risk assessment before prescribing the drug. Massachusetts Governor Deval Patrick attempted an emergency ban of all prescribing and dispensing of Zohydro, but a U.S. District Court Judge struck it down, saying that states should not be allowed to overturn decisions made by the FDA.
Opioid abuse is a growing problem in the United States. In 2010, it was estimated that 1.9 million people in the U.S. were addicted to prescription opioid pain relievers. In 2007, the societal cost of prescription opioid addiction was estimated at $55.7 billion.
On the other hand, there are approximately 100 million Americans who suffer from chronic pain and, for many, non-opioid painkillers don't work. "There will definitely be people out there who will take [Zohydro] exactly as prescribed and benefit from it," says Alford. He says that most people who are prescribed opioids probably follow instructions and even those who become addicted or sell their pills likely also have real chronic pain.
Alford agrees with many others that Zohydro should be kept from the market until there is an abuse-resistant formulation – something its manufacturer, Zogenix, says won't be ready for another two years or so. He also says that, instead of using legal action to regulate the drug, he would rather see better education of the medical professionals who will be tasked with prescribing it. In the meantime, Zohydro may soon have competition. Purdue Pharma recently released the Phase 3 clinical trial results of its own extended-release hydrocodone drug. Its drug, however, is tamper-resistant, which has some people predicting it will knock Zohydro out of the market.
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