Experts Voice Concern Over FDA Approval of New Hydrocodone Drug

The Food and Drug Administration’s (FDA) approval of the first pure hydrocodone drug in the United States concerns law enforcement agencies and addiction experts, who predict overdose deaths will increase, Newsday reports.

The drug, Zohydro ER (extended release), was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Drugs such as Vicodin contain a combination of hydrocodone and other painkillers such as acetaminophen. Zohydro is expected to reach the market in early 2014.

In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction. 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 is potentially 10 times stronger when abused than hydrocodone combination products, according to the article. Zohydro is designed to be released over time, and can be crushed and snorted by people seeking a strong, quick high. The opioid drug OxyContin has been reformulated to make it harder to crush or dissolve, but Zohydro does not include similar tamper-resistant features, the newspaper notes.

Zogenix has started the development of an abuse deterrent formulation of Zohydro , according to a company statement.

“That the FDA has approved another incredibly powerful painkiller without [tamper-proof features] is both disconcerting and dangerous,” said Jeffrey Reynolds, Executive Director of the Long Island Council on Alcoholism and Drug Dependence, who told the FDA expert panel he opposed 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.”

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    Dan Lebowski

    March 7, 2016 at 12:28 PM

    I was diagnosed with an auto-immune disorder known as “mixed connective tissue disease” The disease attacks healthy tissue and is an oscillating disease of overlapping diagnosis. Lupus, RA, Rayneauds Phenomena, sjogrens, Thyroid disease, Plus, various regions of my alimentary canal have been surgically repaired. I mention these facts as a preface to the experience of “pain management”. My doctor knows that I had a DUI in 1998. He has prescibed, over potent opiate ( oxycontin, methadone, hydromorphone, oxymorphone) for sustained comfort and milder opiates for “breakout” pain. Everybody is different but,I have experienced the greatest pain redcing benefits from Hysingla, It is a pure hydrocodone, 24 hour extended releasel The benefits over the oxy’s and morph’s is that it really is far less physically addicting than the heavy hitting oxycontin, dilaudid, and opana. And, I have less worry of liver damage and I’m not on the “craving” roller coaster. With advanced MCTD I was biased about taking hydrocodone. The 80 mg gives remarkable pain relief without the horrible withdrawals of the other junk mentioned. We are human beings, IT IS DEHUMANIZING TO REFER TO A HUMAN IN TERMS THAT CONNOTE SECOND CLASS CITIZENRY.

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    Ed

    February 29, 2016 at 2:35 PM

    My wife is in constant pain but her doctors will not prescribe enough painkiller to keep her low on the pain curve. They are afraid of the DEA so she suffers. Also she is on coumadin anti-coagulation therapy and the inclusion of acetaminophen in hydrocodone messes with her inr and does her liver no good. This problem will not be solved in her lifetime so I guess I am just blowing off steam. Meanwhile the guys on the street are still getting their highs while we suffer.

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    Jessie Smith

    February 12, 2016 at 2:30 AM

    Pain killers can never be expected to give you 100% relief. I just had knee replacement day before yesterday and I’m home and for two days and nights I’ve been trying to catch up to and overcome my pain and I’ve yet it gain control but it’s slowly getting betterI’ve had chronic issues with arthritis which can hurt like hell just with something like waking up with a stiff neck or having the weather change a lot over night. I’ve also gotten a bit too much pain killer in my system trying to get ahold of it and felt a bit “high.” When I’m laying here in acute pain almost in tears it pisses me off to no end to hear the stinkin arguments against something that works and is available. I need something strong enough, to last long enough and not take so much Tylenol with it that I’m going to suffer from acute liver disease pain down the road!

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