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Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users

OBJECTIVE: To assess the intranasal abuse potential of hydrocodone extended-release (ER) tablets developed with CIMA Abuse-Deterrence Technology compared with hydrocodone powder and hydrocodone bitartrate ER capsules (Zohydro ER, original formulation [HYD-OF]). DESIGN: Single-dose, randomized, doubl...

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Autores principales: Bond, Mary, Schoedel, Kerri A, Rabinovich-Guilatt, Laura, Gasior, Maciej, Tracewell, William, Malamut, Richard, Ma, Yuju, Webster, Lynn R
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6084602/
https://www.ncbi.nlm.nih.gov/pubmed/29016880
http://dx.doi.org/10.1093/pm/pnx133
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author Bond, Mary
Schoedel, Kerri A
Rabinovich-Guilatt, Laura
Gasior, Maciej
Tracewell, William
Malamut, Richard
Ma, Yuju
Webster, Lynn R
author_facet Bond, Mary
Schoedel, Kerri A
Rabinovich-Guilatt, Laura
Gasior, Maciej
Tracewell, William
Malamut, Richard
Ma, Yuju
Webster, Lynn R
author_sort Bond, Mary
collection PubMed
description OBJECTIVE: To assess the intranasal abuse potential of hydrocodone extended-release (ER) tablets developed with CIMA Abuse-Deterrence Technology compared with hydrocodone powder and hydrocodone bitartrate ER capsules (Zohydro ER, original formulation [HYD-OF]). DESIGN: Single-dose, randomized, double-blind, quadruple-dummy, active- and placebo-controlled, crossover study. SETTING: One US site. SUBJECTS: Healthy, adult, nondependent, recreational opioid users. METHODS: Subjects able to tolerate intranasal hydrocodone and discriminate hydrocodone from placebo were eligible for study enrollment. Eligible participants randomly received intranasal hydrocodone ER, intranasal hydrocodone powder, intranasal HYD-OF, intact oral hydrocodone ER, and placebo. Coprimary pharmacodynamic end points were a maximum effect on “at the moment” Drug Liking visual analog scale and Overall Drug Liking visual analog scale. Pharmacokinetics and safety were assessed. RESULTS: Mean maximum effect for “at the moment” Drug Liking was significantly (P < 0.01) lower for intranasal hydrocodone ER (72.8) compared with hydrocodone powder (80.2) and HYD-OF (83.2). Similar results were observed for Overall Drug Liking maximum effect (68.5 vs 77.1 and 79.8, respectively; P < 0.01). Secondary end points, including balance of effects and positive, sedative, and other effects, were consistent with these results. Intranasal treatments showed significantly greater effects vs placebo, while intact oral hydrocodone ER was similar to placebo. For each treatment, plasma concentration-time profiles paralleled “at the moment” Drug Liking over time. Incidences of adverse events for intranasal treatments were 52% for hydrocodone ER, 53% for hydrocodone powder, and 61% for HYD-OF. CONCLUSIONS: The statistically significant differences between hydrocodone ER vs hydrocodone powder and HYD-OF for the primary drug liking end points indicate a lower intranasal abuse potential with hydrocodone ER in healthy, nondependent, recreational opioid users.
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spelling pubmed-60846022018-08-14 Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users Bond, Mary Schoedel, Kerri A Rabinovich-Guilatt, Laura Gasior, Maciej Tracewell, William Malamut, Richard Ma, Yuju Webster, Lynn R Pain Med OPIOIDS & SUBSTANCE USE DISORDERS SECTION OBJECTIVE: To assess the intranasal abuse potential of hydrocodone extended-release (ER) tablets developed with CIMA Abuse-Deterrence Technology compared with hydrocodone powder and hydrocodone bitartrate ER capsules (Zohydro ER, original formulation [HYD-OF]). DESIGN: Single-dose, randomized, double-blind, quadruple-dummy, active- and placebo-controlled, crossover study. SETTING: One US site. SUBJECTS: Healthy, adult, nondependent, recreational opioid users. METHODS: Subjects able to tolerate intranasal hydrocodone and discriminate hydrocodone from placebo were eligible for study enrollment. Eligible participants randomly received intranasal hydrocodone ER, intranasal hydrocodone powder, intranasal HYD-OF, intact oral hydrocodone ER, and placebo. Coprimary pharmacodynamic end points were a maximum effect on “at the moment” Drug Liking visual analog scale and Overall Drug Liking visual analog scale. Pharmacokinetics and safety were assessed. RESULTS: Mean maximum effect for “at the moment” Drug Liking was significantly (P < 0.01) lower for intranasal hydrocodone ER (72.8) compared with hydrocodone powder (80.2) and HYD-OF (83.2). Similar results were observed for Overall Drug Liking maximum effect (68.5 vs 77.1 and 79.8, respectively; P < 0.01). Secondary end points, including balance of effects and positive, sedative, and other effects, were consistent with these results. Intranasal treatments showed significantly greater effects vs placebo, while intact oral hydrocodone ER was similar to placebo. For each treatment, plasma concentration-time profiles paralleled “at the moment” Drug Liking over time. Incidences of adverse events for intranasal treatments were 52% for hydrocodone ER, 53% for hydrocodone powder, and 61% for HYD-OF. CONCLUSIONS: The statistically significant differences between hydrocodone ER vs hydrocodone powder and HYD-OF for the primary drug liking end points indicate a lower intranasal abuse potential with hydrocodone ER in healthy, nondependent, recreational opioid users. Oxford University Press 2018-08 2017-06-14 /pmc/articles/PMC6084602/ /pubmed/29016880 http://dx.doi.org/10.1093/pm/pnx133 Text en © 2017 American Academy of Pain Medicine. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle OPIOIDS & SUBSTANCE USE DISORDERS SECTION
Bond, Mary
Schoedel, Kerri A
Rabinovich-Guilatt, Laura
Gasior, Maciej
Tracewell, William
Malamut, Richard
Ma, Yuju
Webster, Lynn R
Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users
title Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users
title_full Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users
title_fullStr Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users
title_full_unstemmed Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users
title_short Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users
title_sort evaluation of the relative intranasal abuse potential of a hydrocodone extended-release tablet formulated with abuse-deterrence technology in nondependent, recreational opioid users
topic OPIOIDS & SUBSTANCE USE DISORDERS SECTION
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6084602/
https://www.ncbi.nlm.nih.gov/pubmed/29016880
http://dx.doi.org/10.1093/pm/pnx133
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