Intranasal Abuse Potential, Pharmacokinetics, and Safety of Once-Daily, Single-Entity, Extended-Release Hydrocodone (HYD) in Recreational Opioid Users

Abstract Objectives. A once-daily, extended-release hydrocodone bitartrate tablet with abuse-deterrent properties (Hysingla ER® [HYD]) is available for the treatment of chronic pain in appropriate patients. This study evaluated the intranasal abuse potential and pharmacokinetics of HYD coarse and fi...

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Bibliographic Details
Published in:Pain medicine (Malden, Mass.) Mass.), 2016-05, Vol.17 (5), p.820-831
Main Authors: Harris, Stephen C., Cipriano, Alessandra, Colucci, Salvatore V., Kapil, Ram P., Geoffroy, Pierre, Hopyan, Talar, Levy-Cooperman, Naama
Format: Article
Language:English
Subjects:
Administration, Intranasal
Adult
Analgesics, Opioid - administration & dosage
Analgesics, Opioid - pharmacokinetics
Chronic pain
Cross-Over Studies
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - pharmacokinetics
Double-Blind Method
Drug abuse
Drug Administration Schedule
Female
GENERAL SECTION
Humans
Hydrocodone - administration & dosage
Hydrocodone - pharmacokinetics
Irritation
Male
Middle Aged
Narcotics
Opioid-Related Disorders - diagnosis
Opioid-Related Disorders - metabolism
Opioids
Pain
Pharmacokinetics
Powder
Powders
Street Drugs - pharmacokinetics
Young Adult
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Summary:Abstract Objectives. A once-daily, extended-release hydrocodone bitartrate tablet with abuse-deterrent properties (Hysingla ER® [HYD]) is available for the treatment of chronic pain in appropriate patients. This study evaluated the intranasal abuse potential and pharmacokinetics of HYD coarse and fine particles vs hydrocodone powder or placebo. Design. Single-center, double-blind, positive- and placebo-controlled, randomized, four-treatment crossover study. Subjects. Healthy adult, nondependent, recreational opioid users with a history of intranasal abuse. Methods. During four treatment periods, subjects (N = 31) received hydrocodone powder 60 mg, HYD coarse particles 60 mg, HYD fine particles 60 mg, or placebo, with five-to-seven-day washouts between treatments. Measures over 36 hours postdose included drug-liking and willingness to take drug again, assessed using visual analog scales (VASs), pupillometry, intranasal irritation, and pharmacokinetics. Results. Insufflation of both HYD coarse and fine particles led to lower “At this Moment” Drug Liking VAS peak values compared with hydrocodone powder, but higher values compared with placebo (P
ISSN:1526-2375
1526-4637
DOI:10.1093/pm/pnv004