Effects of Renal Impairment and Hepatic Impairment on the Pharmacokinetics of Hydrocodone After Administration of a Hydrocodone Extended‐Release Tablet Formulated With Abuse‐Deterrence Technology

Darwish, Mona; Yang, Ronghua; Tracewell, William; Robertson, Philmore; Bond, Mary

doi:10.1002/cpdd.238

Cited by 14 publications

(4 citation statements)

References 26 publications

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“…However, data are extremely limited as described below. There is only a single study that has assessed the extent to which varying degrees of kidney failure can affect the pharmacokinetics of hydrocodone and this involved a single 45-mg dose of extended-release formulation over 144 h (45). All subjects received naloxone at 15 and 3 h before and 9 and 21 h post dose to minimize opioid-related adverse effects.…”

Section: Analgesic Detailsmentioning

confidence: 99%

Clinical Pharmacology Considerations in Pain Management in Patients with Advanced Kidney Failure

Davison¹

2019

CJASN

100

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Pain is common and poorly managed in patients with advanced CKD, likely due to both under and over prescription of appropriate analgesics. Poorly managed pain contributes to patients' poor quality of life and excessive health care use. There is tremendous variability within and between countries in prescribing patterns of analgesics, suggesting that factors other than patient characteristics account for these differences. This article discusses the pharmacologic management of acute and chronic pain in patients with advanced CKD, and the role analgesics, including opioids, play in the overall approach to pain management.

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Section: Analgesic Detailsmentioning

confidence: 99%

Clinical Pharmacology Considerations in Pain Management in Patients with Advanced Kidney Failure

Davison¹

2019

CJASN

100

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“…Plasma levels of hydrocodone and its metabolite, hydromorphone, were quantitated using a validated high-performance liquid chromatography method with tandem mass spectrometric detection as previously described. 17 Briefly, a 100-μL matrix aliquot was fortified with 25 μL of 25 ng/mL internal standard (hydrocodone-d 3 and hydromorphone-d 3 ) working solution. Analytes were isolated through supported liquid extraction using Biotage Isolute SLE+ and eluted with 1.6 mL of dichloromethane.…”

Section: Bioanalytical Methodsmentioning

confidence: 99%

Pharmacokinetic and Pharmacodynamic Correlations From 2 Studies Evaluating Abuse Potential of Hydrocodone Extended‐Release Tablets

Schoedel¹,

Gillespie

Levy‐Cooperman³

et al. 2018

Clinical Pharm in Drug Dev

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Pharmacokinetic (PK)/pharmacodynamic (PD) correlations were explored in 2 human abuse potential studies of orally and intranasally administered hydrocodone extended-release (ER) 45 mg in healthy, nondependent opioid users. In a crossover study design, subjects received intact hydrocodone ER, finely milled hydrocodone ER, and hydrocodone powder in solution in the oral study and finely milled hydrocodone ER, hydrocodone powder, and finely milled Zohydro® ER in the intranasal study. Spearman ρ and Pearson r values were calculated for PD (maximum effect [E ] for "at the moment" Drug Liking, Overall Drug Liking, and Take Drug Again visual analog scales [VAS]) vs PK (partial area under the concentration-time curve [AUC], maximum drug concentration [C ], time to C [T ], and abuse quotient [PK AQ; C /T ]) for all treatments. In the oral study, correlations were strongest between E of "at the moment" Drug Liking and PK parameters (C [ρ = 0.4446], PK AQ [ρ = 0.5179], T [ρ = 0.5093], and early systemic exposure [ρ = 0.4782]). For Overall Drug Liking and Take Drug Again VAS, ρ values for correlations with PK parameters ranged from 0.2620 to 0.3637. In the intranasal study, no clear correlations between PK and PD parameters were apparent.

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“…Plasma concentrations of hydrocodone and its active metabolite, hydromorphone, were determined by Pharmaceutical Product Development (Richmond, VA, USA) using a validated high-performance liquid chromatography method with tandem mass spectrometric detection. The validated quantifiable range of the assay was 0.100 to 100 ng/mL for hydrocodone and 0.0500 to 50.0 ng/mL for hydromorphone (bioanalytical methods same as previously described by Darwish et al [ 20 ]).…”

Section: Methodsmentioning

confidence: 99%

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

Bond

Schoedel²,

Rabinovich‐Guilatt

et al. 2017

Pain Medicine

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ObjectiveTo 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]).DesignSingle-dose, randomized, double-blind, quadruple-dummy, active- and placebo-controlled, crossover study.SettingOne US site.SubjectsHealthy, adult, nondependent, recreational opioid users.MethodsSubjects 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.ResultsMean 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.ConclusionsThe 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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Effects of Renal Impairment and Hepatic Impairment on the Pharmacokinetics of Hydrocodone After Administration of a Hydrocodone Extended‐Release Tablet Formulated With Abuse‐Deterrence Technology

Cited by 14 publications

References 26 publications

Clinical Pharmacology Considerations in Pain Management in Patients with Advanced Kidney Failure

Clinical Pharmacology Considerations in Pain Management in Patients with Advanced Kidney Failure

Pharmacokinetic and Pharmacodynamic Correlations From 2 Studies Evaluating Abuse Potential of Hydrocodone Extended‐Release Tablets

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

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