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A tale of 2 ADFs: differences in the effectiveness of abuse-deterrent formulations of oxymorphone and oxycodone extended-release drugs

Cicero, Theodore J.; Ellis, Matthew S.; Kasper, Zachary A.

doi: 10.1097/j.pain.0000000000000511
Research Paper
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The introduction of extended-release opioid analgesics helped initiate an epidemic of prescription opioid abuse in the United States. To make access to the drug by crushing or dissolution more difficult, abuse-deterrent formulations (ADFs) of OxyContin (Purdue Pharma, Stamford, CT) and Opana ER (Endo Pharmaceuticals Inc., Malvern, PA), which use the same foundation technology (Intac, Grunenthal, Aachen, Germany), were introduced in 2010 and 2012, respectively. To examine their relative effectiveness, we used a structured survey of 12,124 individuals entering treatment for opioid use disorder followed by a more focused online survey with a subset of these patients (N = 129) using both structured and open-ended questions. Data showed that the OxyContin ADF was highly effective in reducing nonoral abuse (91.4% before the ADF, 47.9% afterwards), particularly with insufflation (78%-28.8%) and intravenous injection of the active drug (42.7%-21.4%). However, although the Opana ER ADF was effective in reducing insufflation (80%-37.1%), injection (60.0%-51.4%), and overall nonoral abuse (94.3%-77.1%), it showed no significant decrease over time. Bearing in mind that the Opana ER sample was smaller in size than that for OxyContin, our results nonetheless suggest disparate outcomes resulting from the introduction of the ADFs, which could indicate that an ADF's effectiveness may be drug-specific. Given the public health impact of prescription opioids and the considerable effort being expended to develop ADFs as a partial solution to the problem, our preliminary studies suggest that each ADF must be evaluated on its own merits even if the same proprietary technology is used.

Supplemental Digital Content is Available in the Text.Effectiveness of abuse-deterrent formulations may be drug-specific, with variances in technology and the value of its “high” as probable causes for differences in ADF impacts.

Department of Psychiatry, Washington University, St. Louis, MO, USA

Corresponding author. Address: Department of Psychiatry, Washington University in St. Louis, Campus Box 8134, 660 S. Euclid Ave, St. Louis, Missouri 63110, USA. Tel.: 314-362-0459; fax: 314-362-0936. E-mail address: Cicerot@wustl.edu (T. J. Cicero).

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.painjournalonline.com).

Received September 21, 2015

Received in revised form January 06, 2016

Accepted January 28, 2016

© 2016 International Association for the Study of Pain
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