Abuse of Reformulated OPANA® ER: early findings from NAVIPPRO® data

Theresa A. Cassidy, MPH, Emily C. McNaughton, MPH , Kimberly Lobo, MPH , Simon H. Budman, PhD, Stephen F. Butler, PhD
Presented at American Society of Addiction Medicine (ASAM), Chicago, IL, April 25-27th, 2013 

“Abuse of Reformulated OPANA® ER: early findings from NAVIPPRO® data”

Summary: Reformulated extended release (ER) oxymorphone (OPANA ER; Endo Pharmaceuticals Inc., Chadds Ford, PA) was approved in December 2011 and released in February 2012. The reformulation has physicochemical resistance to crushing and dissolution intended to present obstacles to abuse by non-oral routes of administration (ROA, e.g., injecting, snorting). Initial observations regarding abuse of oxymorphone ER after its reformulation were gathered using two NAVIPPRO data sources.

Methods: The ASI-MV (Addiction Severity Index-Multimedia Version), a computer-administered interview, collects self-report of past 30 day substance abuse, including prescription opioids, among adults assessed for substance abuse and treatment planning. WIS (Web-Informed Services) collects discussion among individuals on eight drug-related websites. Ongoing surveillance data collected on reformulated oxymorphone ER will be reviewed and compared to abuse of other prescription opioid analgesics.

Results: Observations from 12,099 assessments during the second quarter of 2012 indicate lower abuse of reformulated oxymorphone ER (0.31 cases per 100 assessments) versus comparator opioid compounds (hydromorphone and morphine ER; 1.29 and 0.98 cases per 100 assessments, respectively). Of those who abused reformulated oxymorphone ER (n = 38), most administered the product orally (71.1%, n = 27), followed by injection (21.1%, n = 8) and snorting (15.8%, n = 6). Data from Internet discussions suggests dislike and frustration with the reformulation among recreational drug users including conversation indicating difficulty tampering with and use of the product via alternate ROAs. Posts regarding reformulated oxymorphone ER will be further examined to understand recreational drug users reactions to the new tablet.

Conclusion: These observations provide a preliminary impression of reformulated oxymorphone ER abuse from two large national data sources.