Highlights
- •Abuse liability of the tapentadol active pharmaceutical ingredient (API) is compared with those of other scheduled opioids.
- •Population-level event rates of tapentadol API abuse were lower than comparators.
- •Drug availability adjusted event rates of tapentadol abuse were low but not lowest.
- •Public health burden of tapentadol API appears to be low.
Abstract
Tapentadol, a Schedule II opioid with a combination of µ-opioid activity and norepinephrine
reuptake inhibition, is used for the management of moderate to severe acute and chronic
pain. Its dual mechanism of action is thought to reduce opioid-related side effects
that can complicate pain management. Since approval, tapentadol has been tracked across
multiple outcomes suggesting abuse liability, and a pattern of relatively low, although
not absent, abuse liability has been found. This retrospective cohort study further
details the abuse liability of tapentadol as an active pharmaceutical ingredient (API)
when immediate-release as well as extended-release formulations were on the market
together (fourth quarter of 2011 to second quarter of 2016). Tapentadol (API) was
compared with tramadol, hydrocodone, morphine, oxycodone, hydromorphone, and oxymorphone
across Poison Center, Drug Diversion, and Treatment Center Programs Combined data
streams from the Researched Abuse, Diversion and Addiction-Related Surveillance system.
Findings suggest the public health burden related to tapentadol to date is low, but
present. Event rates of abuse per population-level denominators were significantly
lower than all other opioids examined. However, when adjusted for drug availability,
event rates of abuse were lower than most Schedule II opioids studied, but were not
the lowest. Disentangling these 2 sets of findings further by examining various opioid
formulations, such as extended-release and the role of abuse-deterrent formulations,
is warranted.
Perspective
This article presents the results from an examination of tapentadol API across the
Researched Abuse, Diversion and Addiction-Related Surveillance System: a broad and
carefully designed postmarketing mosaic. Data to date from Poison Center, Drug Diversion,
and Treatment Centers combined suggest a low, but present public health burden related
to tapentadol.
Key words
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Article info
Publication history
Published online: December 07, 2017
Accepted:
November 29,
2017
Received in revised form:
October 18,
2017
Received:
June 28,
2017
Footnotes
The Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System is supported by subscriptions from pharmaceutical manufacturers for surveillance, research and reporting services. The RADARS System is the property of Denver Health and Hospital Authority (DHHA), a political subdivision of the State of Colorado. Denver Health retains exclusive ownership of all data, databases, and systems. Subscribers do not participate in data collection or analysis, nor do they have access to the raw data. Depomed is a RADARS System subscriber. Scientists from Depomed reviewed the draft manuscript for propriety information, however, all final content decisions were made by the RADARS System.
S.K.V. is a scientific consultant with RADARS System and received compensation for preparation of this article. S.K.V. has consulted with Grünenthal, USA. T.J.C., S.P.K., and M.W.P. are compensated for participation on the RADARS System Scientific Advisory Board, and DHHA contracts with these authors' institutions for the operation of RADARS System programs that provided some of the data for this study. S.G.S., R.C.D. and J.L.D. are employees of DHHA.
Identification
Copyright
© Published by Elsevier Inc. on behalf of the American Pain Society
