FDA Approves New Hydrocodone Painkiller

FDA Approves New Hydrocodone Painkiller

The U.S. Food and Drug Administration has approved a new extended release version of hydrocodone – an opioid pain reliever that will be the first and only hydrocodone product to be marketed with an abuse deterrent formula.

The potent painkiller – which will be sold by Purdue Pharma under the brand name Hysingla ER – gives stiff competition to Zohydro, a controversial hydrocodone medication that was introduced earlier this year without abuse-deterrent properties. Hysingla is designed to be taken once a day, while Zohydro is meant to be taken twice a day to relieve chronic pain.

Image courtesy of Purdue Pharma.

Image courtesy of Purdue Pharma.

Hysingla’s formulation makes it more difficult for drug abusers to crush or liquefy for snorting or injecting. The FDA noted, however, that abuse of Hysingla is “still possible” and taking too much of it can lead to overdose and death.

“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

Hydrocodone combination drugs such as Vicodin are the most commonly prescribed and abused painkillers in the country with over 130 million prescriptions annually.

Last month, the Drug Enforcement Administration reclassified all hydrocodone products as Schedule II medications to make them more difficult to get. As a result, many pain patients with legitimate prescriptions for hydrocodone say pharmacists are refusing to fill their prescriptions or claiming the drug is out of stock.

Unlike Vicodin and other hydrocodone combinations, Hysingla and Zohydro are “pure” hydrocodone medications that do not contain acetaminophen or other pain relievers that can have side effects such as liver toxicity.

“Hysingla ER is not approved for, and should not be used for, as-needed pain relief. Given Hysingla ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management,” the FDA said in a statement.

“Hysingla ER does not carry the serious liver toxicity risks associated with hydrocodone combination products containing acetaminophen.”

Purdue expects to launch Hysingla ER in early 2015 in dosage strengths of 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg.

The safety and effectiveness of Hysingla ER were evaluated in a clinical trial of 905 people with chronic low back pain. Additional studies were conducted to demonstrate its abuse-deterrent features. The most common side effects of Hysingla ER are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache and drowsiness.  The FDA is also requiring postmarketing studies of Hysingla ER to assess its risks for abuse.

“The burden of chronic pain and the abuse of prescription medications are both pressing societal problems,” said Charles E. Argoff, MD, Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York.

“Opioids are an essential tool in our arsenal of medical treatments options, so greater availability and use of opioid analgesics with abuse-deterrent properties has the potential to help alleviate suffering among people with chronic pain while reducing the abuse of these medications. Furthermore, this product gives treatment providers the option to use hydrocodone without acetaminophen if they are concerned that their patients may be taking too much acetaminophen on a daily basis.”

Zogenix, the San Diego-based maker of Zohydro, is working on its own abuse deterrent formula for Zohydro. Teva Pharmaceuticals is also developing on a similar hydrocodone product.

Authored by: Pat Anson, Editor

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Jon

If I’m presently using 7.5-325 hydro codons what strength should I ask for. Presently taking 2 per day.

Thx
Jon

I would pay anything.

I have horrible neurophy. Please prescribe something that can help me.

chris

zohydro is a great pain med for chronic pain management. for me to be able to take med without acetaminophen is a game changer. and for me extended release works so much better throughout the day for continuous pain relief

I don’t get it. I’ve been taking Norco for around seven years now. It barely touches the pain. I certainly don’t get high from it. I refuse to take anything stronger. It’s so unfair that the abusers are making it very difficult for true chronic pain sufferers to get even a little bit of relief. It would be very nice to get something to take once a day and the elimination of acetaminophen is a huge bonus.

Charles Lucas

Thank God for round the clock opioid pain killers that do not have acetaminophen in them. As a pain patient with liver disease I avoid acetaminophen at if possible. I can remember asking my doctor 14 years ago to look up something with less Tylenol in it and he came up with Norco 10/325 which still had acetaminophen in it. So kudos to the drug companies and the FDA for approving them. Not my fault other can will probably abuse this drug and I will never get it because I now have a pain pump which I did not want because the orals were working fine.

JON MORGAN-PARKER

All I can say is , I can’t wait for the Snake venom medical trials to be released. Another great step in the righ direction of chronic pain relief.

Clint

Cue the Addiction Catastrophizers: Holder, PROP, Kolodny, Gelfand, Tompson, Skolek, Juurlink, Coelho, Graves, etc., who scheme to throw those in pain under the bus, stuff what’s left of them into Phoenix House ($$$), and finally, whack them out on buprenorphine (more $$$).