FDA's OK of opioid overdose treatment doesn't quell backlash over Zohydro

FDA Commissioner Margaret Hamburg--FiercePharma file photo
FDA Commissioner Margaret Hamburg

The FDA has been getting slapped around by lawmakers after its decision last year to approve Zohydro, a pure hydrocodone drug that has no tamper-resistant technology tied to it. So FDA Commissioner Margaret Hamburg Thursday used the approval of a new overdose treatment that anyone can carry to make her case that the FDA is just as concerned as everyone else about opioid drug abuse in the country.

"Tackling the opioid epidemic is a high priority for the FDA," she said during a briefing, The New York Times reports, adding that the device is "an extremely important innovation that will save lives." The commissioner acknowledged in a statement beforehand that opioid addiction is a serious problem in this country and that overdose is the leading cause of injury fatalities, surpassing car crashes at about 17,000.

The new treatment from Kaléo is called Evzio and contains one dose of naloxone, a drug used by doctors and medics to reverse the effects of an overdose. Approved ahead of schedule, the product is special in that it is an EpiPen-like handheld device that can easily be used by family or friends of people known to abuse opioids or heroin. It has a retractable needle and would be used on someone who has stopped breathing or lost consciousness from an overdose.

The new product was applauded by doctors who deal with pain and addition, but some say federal authorities should be doing far more to deal with the rising toll of abuse that has come as the FDA has approved oxycodone products for pain treatment. Pain specialist Dr. Nathaniel Katz at Tufts University School of Medicine in Boston called the approval a "big deal" in dealing with the problem but then criticized the government for not requiring doctors to get training before being allowed to prescribe opioids, something Hamburg agreed should be mandatory. "They're plucking the low-lying fruit, but the hard things haven't been done," the Times quoted Katz as saying.

The FDA has experienced a growing backlash after approving Zohydro in December, even though the agency's own expert panel voted overwhelmingly against allowing it onto the market. State attorneys general urged the FDA to reconsider. Congress called a hearing, and Sen. Joe Manchin (D-WV) introduced a bill that would force the agency to pull the drug. Last week, Massachusetts Gov. Deval Patrick announced he was banning Zohydro from his state until its maker, Zogenix ($ZGNX), develops an abuse-deterrent version.

The FDA continues to defend the decision, saying that the longer-acting Zohydro is needed by patients in excruciating pain. Meanwhile, OxyContin maker Purdue Pharma says it's working on a tamper-resistant version of hydrocodone, a move that could squash Zogenix's version. But Hamburg has dismissed the tamper-resistant technology as the answer to the problem, saying the technology on the market today is "poor."

- here's the FDA announcement
- read the NYT story (sub. req.)

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