A Healthesystems publication

Spring 2014

Zohydro ER: Proceed With Caution

Controversy surrounded the FDA approval of Zohydro ERTM due to safety concerns. This powerful, long-acting new opioid lacks abuse-deterrent properties and is now on the market. Its use should be discouraged.

Zohydro ERTM (hydrocodone bitartrate extended-release capsules) received FDA approval in October 2013, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, for which alternative treatment options are inadequate.92 It is the first formulation of hydrocodone as a single entity — meaning it is not combined with an analgesic such as acetaminophen — and the first extended-release hydrocodone formulation. Zohydro is in the same high-risk category as other opioid products such as OxyContin® (oxycodone extended-release tablet) and Exalgo® (hydromorphone extended-release tablet). However, unlike other extended-release opioids, Zohydro ER is not abuse-deterrent and has the potential to be crushed easily or chewed.

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SOURCES

1 -FDA News Release: FDA approve extended-release, single-entity hydrocodone product. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm372287.htm. Published October 25th, 2013. Accessed December 27, 2013.
2 -CNN Health. New pain pill’s approval: ‘Genuinely frightening’. http://us.cnn.com/2014/02/26/health/zohydro-approval/index.html?sr=sharebar_twitter. Published February 26, 2014. Accessed February 3rd, 2014.
3 -A Communication from the Chief Legal Officers. State Attorneys General. Published December 10, 2013. http://ag.ky.gov/pdf_news/zohydro-letter.pdf. December 10, 2013. Accessed December 27, 2013.
4 -USA Today. Attorneys general seek to pull ‘powerful’ painkiller. http://www.usatoday.com/story/news/nation/2014/03/27/attorneys-general-oppose-painkiller-zohydro/6949547/. Published March 27, 2014. Accessed March 27, 2014.
5 -Rauck RL, Nalamachu S, Wild JE. Single-entity hydrocodone extended release for chronic low back pain. PainWEEK. 2012. http://www.zogenix.com/pdf/Zohydro%20801%20Study%20PAINWeek%202012%20poster%20-%20final.pdf. Accessed January 20, 2014.
6 -Food and Drug Administration Center of Drug Evaluation and Research. FDA Background Material NDA 202880 Zohydro ER (hydrocodone) for the management of moderate to severe chronic pain. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM330683.pdf. December 7, 2012. Accessed December 27, 2013
7 -Moorman-Li R, Motycka CA, Inge LD. A review of abuse-deterrent opioids for chronic nonmalignant pain. P T. 2012;37(7):412-418.
8 -A Communication from the Chief Legal Officers. State Attorneys General. Published December 10, 2013. http://ag.ky.gov/pdf_news/zohydro-letter.pdf. December 10, 2013. Accessed December 27, 2013.
9 -FDA News Release: FDA announces safety labeling changes and post-market study requirements for extended-release and long-acting opioid analgesics. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367726.htm. Published September 10, 2013. Accessed December 27, 2013.
10 -CNN Health. New pain pill’s approval: ‘Genuinely frightening’. http://us.cnn.com/2014/02/26/health/zohydro-approval/index.html?sr=sharebar_twitter. Published February 26, 2014. Accessed February 3rd, 2014.
11 -IntellitabTM - for Safer Controlled Release. Altus Formulation Inc. http://www.altusformulation.com/ourtechnologies/intellitab.html. Published 2012. Accessed January 20, 2014.
12 -Cicero TJ, Ellis MS, Surratt HL, et al. Effect of abuse-deterrent formulation of OxyContin. 2012. N Engl J Med 367:187–9
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