A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Intranasal Human Abuse Potential Study of Oxycodone ARIR, a Novel, Immediate-Release, Abuse-Deterrent Formulation.
Abuse-Deterrent
Drug Liking
Intranasal
Opioid
Oxycodone
Journal
Pain medicine (Malden, Mass.)
ISSN: 1526-4637
Titre abrégé: Pain Med
Pays: England
ID NLM: 100894201
Informations de publication
Date de publication:
01 04 2019
01 04 2019
Historique:
pubmed:
3
4
2018
medline:
20
8
2019
entrez:
3
4
2018
Statut:
ppublish
Résumé
Prescription opioid abuse continues to be a public health concern. Oxycodone ARIR is an immediate-release (IR) oxycodone tablet composed of multiple overlapping barriers that deter manipulation of the tablet for non-oral abuse. This randomized, double-blind, double-dummy, active- and placebo-controlled, four-way crossover, intranasal human abuse potential study assessed the pharmacodynamics and pharmacokinetics of crushed intranasal oxycodone ARIR compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR. Pharmacodynamic end points included mean maximum drug liking (Emax), as measured by subjects on a bipolar 100-mm visual analog scale (primary), and desire to take the drug again, overall drug liking, drug high, and good effects (secondary). Pharmacokinetic assessments included peak concentration and time to peak concentration. Twenty-nine subjects completed the treatment phase. Crushed intranasal oxycodone ARIR demonstrated a significant reduction of 46.9% and 23.4% in drug liking Emax compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR, respectively (P < 0.0001 for both). Significant reductions also were observed in desire to take the drug again, drug high, overall drug liking, and good effects when comparing crushed intranasal oxycodone ARIR with crushed intranasal IR oxycodone and intact oral oxycodone ARIR (P < 0.001 for all). Crushed intranasal oxycodone ARIR exhibited lower peak oxycodone plasma concentrations and slower time to peak concentration compared with crushed intranasal IR oxycodone and intact oral oxycodone ARIR. All treatments were well tolerated; adverse effects were typical of opioids or intranasal administration. These data indicate that oxycodone ARIR has the potential to reduce abuse via the intranasal route.
Identifiants
pubmed: 29608768
pii: 4956036
doi: 10.1093/pm/pny043
pmc: PMC6542380
doi:
Substances chimiques
Abuse-Deterrent Formulations
0
Analgesics, Opioid
0
Tablets
0
Oxycodone
CD35PMG570
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
747-757Informations de copyright
© 2018 American Academy of Pain Medicine.
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