The shock felt after the FDA’s recent approval of the new pain medication Zohydro wasn’t limited to advocacy groups and addiction treatment specialists. Even those on the FDA advisory committee were startled by it, considering that they had voted 11-to-2 against approval of the drug.
As much as 10 times more powerful than other painkiller in its class, Zohydro is not messing around.
‘It Will Kill People As Soon As It’s Released’
Zohydro was developed by pharmaceutical giant Zogenix. One capsule of the painkiller packs enough hydrocodone to kill a child, a doctor wrote recently in the Huffington Post. If taken by an adult unaccustomed to opioids, the medication could result in death.
“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” said Dr. Andrew Kolodny, chief medical officer at Phoenix House, an addiction treatment center. “It will kill people as soon as it’s released.”
Besides its potency, Zohydro raises concerns for another feature: how easy the capsules are to crush. Crushed capsules make for a powder that can be injected or snorted by drug abusers for a faster, more potent high. This has been an issue with other opioids, like OxyContin.
But the case against Zohydro isn’t just the ease of non-prescription uses, as Dr. Andrew Kolodny, chief medical officer of Phoenix House, reports. The real problem with this “genuinely frightening” drug, he writes, is the same problem with all opioids used in long-term pain management: the law of diminishing returns.
A Poor Long-Term Option
And that’s because opioids, while highly effective as painkillers in an acute sense, quickly create a tolerance in patients. Simply put: over time, more and more of the drug is required to reach the same result.
Dr. Jevtovic-Todorovic, a long-time anesthesiologist and a member of the FDA advisory panel, put it succinctly: “Opiates are lousy drugs to treat chronic pain.”
The Battle Continues
More than forty organizations have sent a letter asking the FDA to rescind its approval and keep Zohydro off the market. Signers included Blue Cross Blue Shield, the American Society of Addiction Medicine, and some of the country’s most prominent addiction treatment agencies.
In the meantime, Zogenix has launched its own campaign of persuasion with the FDA. CEO Roger Hawley announced this week that Zogenix is establishing an external board that will report “independent” assessments and recommendations to the FDA regarding Zohydro.
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