Evaluation of the Relative Abuse of an OROS Extended-release Hydromorphone HCI Product: Results From 3 Postmarket Surveillance Studies.

Author(s)

Stephen F. Butler
Emily C. McNaughton
Ryan A. Black, Nova Southeastern UniversityFollow
Theresa A Cassidy

Document Type

Article

Publication Title

The Clinical journal of pain

ISSN

1536-5409

Publication Date

7-1-2018

Abstract

OBJECTIVE: Formulating prescription opioids to limit abuse remains a priority. OROS extended-release (ER) hydromorphone HCl (EXALGO) may have lower abuse potential than many other opioid products. Three postmarketing studies of the relative abuse liability of OROS hydromorphone ER were conducted.

METHODS: Estimates of abuse, unadjusted, and adjusted for prescription volume, were generated for OROS hydromorphone ER and comparators from Q2 2010 through Q2 2014 for a high-risk, substance abuse treatment population and the general population using poison control center data. Comparators were selected for compound, market penetration, and route of administration (ROA) profile. ROA comparisons were made among the substance abuse treatment population. Internet discussion was examined to determine abusers' interest in and desire for the OROS formulation.

RESULTS: Examination of abuse prevalence among adults within substance abuse treatment, intentional poison exposures, and Internet discussion levels generally support the hypothesis that OROS hydromorphone ER may have lower abuse potential than many other opioid products. OROS hydromorphone ER also seems to be abused less often by alternate ROAs (eg, snorting and injection). Lower levels of online discussion were observed along with relatively low endorsement for abuse.

DISCUSSION: Abuse of OROS hydromorphone ER was observed in high-risk substance abuse and general population samples but at a very low relative prevalence compared to comparators. Evidence suggests it may be less often abused by alternate ROAs than some comparators. Online data did not find evidence of high levels of desire for OROS hydromorphone ER by recreational abusers. Continued monitoring of this product's abuse liability is warranted.

DOI

https://doi.org/10.1097/AJP.0000000000000585

Volume

34

Issue

7

First Page

618

Last Page

628

PubMed ID

29298186

NSUWorks Citation

Butler, S. F., McNaughton, E. C., Black, R. A., Cassidy, T. (2018). Evaluation of the Relative Abuse of an OROS Extended-release Hydromorphone HCI Product: Results From 3 Postmarket Surveillance Studies.. The Clinical journal of pain, 34(7), 618-628.
Available at: https://nsuworks.nova.edu/cps_facarticles/1614