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Human Abuse Potential of the New Opioid Analgesic Molecule NKTR-181 Compared with Oxycodone.


ABSTRACT: Objective:Evaluate the human abuse potential, pharmacokinetics, pharmacodynamics, and safety of NKTR-181, a novel mu-opioid agonist molecule, relative to oxycodone. Design:This randomized, single-center, double-blind, active- and placebo-controlled five-period crossover study enrolled healthy, adult, non-physically dependent recreational opioid users. Setting:Inpatient clinical research site. Subjects:Forty-two randomized subjects (73.8% male, 81% white, mean age?=?25 years). Methods:The primary objective was to evaluate single orally administered 100, 200, and 400?mg NKTR-181 doses in solution compared with 40?mg oxycodone and placebo solutions using the Drug Liking visual analog scale. Secondary measures included the Drug Effects Questionnaire, Addiction Research Center Inventory/Morphine Benzedrine Group Subscale, Price Value Assessment Questionnaire, Global Assessment of Overall Drug Liking, and Take Drug Again Assessment. Central nervous system mu-opioid effects were assessed using pupillometry. The study included qualifying and treatment phases. Subjects received each of the five treatments using a crossover design. Results:NKTR-181 at all dose levels had significantly lower Drug Liking Emax than oxycodone (P?

SUBMITTER: Webster L 

PROVIDER: S-EPMC5914314 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Human Abuse Potential of the New Opioid Analgesic Molecule NKTR-181 Compared with Oxycodone.

Webster Lynn L   Henningfield Jack J   Buchhalter August R AR   Siddhanti Suresh S   Lu Lin L   Odinecs Aleksandrs A   Di Fonzo Carlo J CJ   Eldon Michael A MA  

Pain medicine (Malden, Mass.) 20180201 2


<h4>Objective</h4>Evaluate the human abuse potential, pharmacokinetics, pharmacodynamics, and safety of NKTR-181, a novel mu-opioid agonist molecule, relative to oxycodone.<h4>Design</h4>This randomized, single-center, double-blind, active- and placebo-controlled five-period crossover study enrolled healthy, adult, non-physically dependent recreational opioid users.<h4>Setting</h4>Inpatient clinical research site.<h4>Subjects</h4>Forty-two randomized subjects (73.8% male, 81% white, mean age = 2  ...[more]

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