Advanced search
Publication Cover
Current Medical Research and Opinion Volume 35, 2019 - Issue 9
Submit an article Journal homepage
2,993
Views
5
CrossRef citations to date
0
Altmetric
Pain

Assessment of potentially abuse-related events in two phase 3 studies of NKTR-181, a novel opioid analgesic, using the MADDERS® system (Misuse, Abuse, and Diversion Drug Event Reporting System)

Ryan K. LanierAnalgesic Solutions, Wayland, MA, USA; Correspondence[email protected]
,
Jack E. HenningfieldDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA; ;Pinney Associates, Bethesda, MD, USA;
,
Jeffrey GudinPain Management Center, Englewood Hospital and Medical Center, Englewood, NJ, USA;
,
Richard RauckCenter for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA;
,
Harrison ElderAnalgesic Solutions, Wayland, MA, USA;
,
Nathalie ErpeldingAnalgesic Solutions, Wayland, MA, USA;
,
Roi TreisterFaculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel;
,
Joseph GimbelArizona Research Center, Phoenix, AZ, USA;
,
Mary TagliaferriNektar Therapeutics, San Francisco, CA, USA;
,
Stephen K. DobersteinNektar Therapeutics, San Francisco, CA, USA;
,
Carlo J. Di FonzoNektar Therapeutics, San Francisco, CA, USA;
,
Lin LuNektar Therapeutics, San Francisco, CA, USA;
,
Suresh SiddhantiNektar Therapeutics, San Francisco, CA, USA;
&
Nathaniel P. KatzAnalgesic Solutions, Wayland, MA, USA; ;Tufts University School of Medicine, Boston, MA, USA
 show all
Pages 1513-1522 | Received 24 Jan 2019, Accepted 11 Mar 2019, Published online: 01 Apr 2019

References

  • Denisco RA, Chandler RK, Compton WM. Addressing the intersecting problems of opioid misuse and chronic pain treatment. Exp Clin Psychopharmacol. 2008;16:417–428.
  • Hall AJ, Logan JE, Toblin RL, et al. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA. 2008;300:2613–2620.
  • Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry: assessment of abuse potential of drugs. Maryland: FDA; 2017.
  • Smith SM, Paillard F, McKeown A, et al. Instruments to identify prescription medication misuse, abuse, and related events in clinical trials: an ACTTION systematic review. J Pain. 2015;16:389–411.
  • Smith SM, Jones JK, Katz NP, et al. Measures that identify prescription medication misuse, abuse, and related events in clinical trials: ACTTION critique and recommended considerations. J Pain. 2017;18:1287–1294.
  • Treister R, Trudeau JJ, Van Inwegen R, et al. Development and feasibility of the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS®). Am J Addict. 2016;25:641–651.
  • Smith SM, Dart RC, Katz NP, et al. Analgesic, Anesthetic, and Addiction Clinical Trials, Translations, Innovations, Opportunities, and Networks (ACTTION) public–private partnership. Classification and definition of misuse, abuse, and related events in clinical trials: ACTTION systematic review and recommendations. Pain. 2013;154:2287–2296.
  • Miyazaki T, Choi IY, Rubas W, et al. NKTR-181: a novel mu-opioid analgesic with inherently low abuse potential. J Pharmacol Exp Ther. 2017;363:104–113.
  • Markman J, Gudin J, Rauck R, et al. Summit-07: a randomized trial of NKTR-181, a new molecular entity, full mu-opioid receptor agonist for chronic low-back pain. Pain. 2019 [cited Mar 1].
  • Lanier RK, Kazam I, Elder H, et al. Evaluation of potentially abuse-related events in phase 3 clinical trials of cannabidiol (Epidiolex®) using the MADDERS® prospective system. Poster presented at the 79th annual meeting of the College on Problems of Drug Dependence. 2017 Jun 17–22; Montreal, Canada.
  • Webster L, Henningfield J, Buchhalter AR, et al. Human abuse potential of the new opioid analgesic molecule NKTR-181 compared with oxycodone. Pain Med. 2018;19:307–318.
  • Adams EH, Breiner S, Cicero TJ, et al. A comparison of the abuse liability of tramadol, NSAIDs, and hydrocodone in patients with chronic pain. J Pain Symptom Manage. 2006;31:465–476.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.