FDA Panel Votes Against Recommending Zohydro for Approval

A panel of experts assembled by the U.S. Food and Drug Administration (FDA) voted against recommending approval of the painkiller Zohydro ER on Friday. The panel cited concerns over the potential for addiction, Reuters reports.

FDA officials said they could still approve the painkiller by imposing safety restrictions.

In the 11-2 vote against approval, the panel said that while the drug’s maker, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone. Zohydro contains the opioid hydrocodone. Unlike some hydrocodone products such as Vicodin, Zohydro does not contain acetaminophen.

The FDA will decide by March 1 whether to approve Zohydro for sale in the United States for people who need an around-the-clock painkiller for an extended period.

Emergency room visits related to hydrocodone have soared since 2000.

“Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue,” Stephen Farr, PhD, President and Chief Operating Officer of Zogenix, said in a statement. “However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population.”

In a letter sent to FDA Commissioner Margaret Hamburg, MD, before the panel vote, Steve Pasierb, President and CEO of the Partnership for Drug-Free Kids urged the agency not to approve Zohydro ER without requiring it to have tamper-resistant features. “If all extended-release opiate products were required to incorporate tamper-resistant technology, we believe that we would start seeing a beneficial societal impact of less abuse of opioid products, fewer prescription drug overdoses, and fewer deaths,” he wrote. “As a public policy matter, we should all be encouraging companies to ‘retrofit’ their current products so that they are more difficult to abuse. And we certainly should not be approving any new opiates without these protections.”

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    Val

    September 14, 2014 at 5:59 PM

    It doesn’t take a rocket scientist to understand when pharmaceuticals are not available to drug abusers then instead they will use street drugs such as Heroin. And indeed we’ve saw the rise in Heroin use soon after Oxycontin was made tamper resistant.

    Yet chronic pain patients have as many barriers to accessing proper pain care even though most pain relievers have been made tamper proof. The whole purpose for reformatting pain relievers as tamper proof was to halt or slow down abuse. Well, if abuse has slowed down than why is just as hard if not harder for chronic pain patients to access proper and adequate pain care?

    The non-tamper proof generic version of this medicine is still available for sale to patients in Canada but not in the USA. Instead USA patients must pay for the highest cost for any brand name medicines.

    I am a health aid and I know the current cost for this medicine is over $500.00 a month with Medicare Part D. Yet it was less than $100.00 before being remanufactured.
    When are we going to put the rights of chronic care patients before drug addicts?

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    Mystique Brent

    May 19, 2014 at 10:57 PM

    I care gave my dear wife who has M.S and is still suffering after 20 yrs.
    and is now been in three nursing homes. It took me 5 years to convince her sadistic doctor. to administrate pain med.
    I had valve heart surgery that I died of from bleeding out they had to reopen me and do the surgery over again in the same session I lost 1 1/2 pints of blood.
    And after the surgery the surgeon and his team were angry at me for there screw up.
    I am transgender and they had problems with that. They with held pain meds put something on my body that made my skin feel like it was on fire for 12 hours.
    I am still in more pain than ever and have a hard time getting strong enough pain meds .
    because of the close minded doctors who need to find there compassion .

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