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Cited by 35Pharmacogenetics and Drug MetabolismPharmacology and Obesity TreatmentForensic Toxicology and Drug Analysis

Intranasal versus Oral Administration of Lisdexamfetamine Dimesylate: A Randomized, Open-Label, Two-Period, Crossover, Single-Dose, Single-Centre Pharmacokinetic Study in Healthy Adult Men

Ermer, James C., Dennis, Kerry, Haffey, Mary B., Doll, Walter J., Sandefer, Erik P., Buckwalter, Mary, Page, Richard C., Diehl, Brian +1 more·2011·Clinical Drug Investigation
DOI 10.2165/11588190-000000000-00000
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Abstract

Background and objective Data on pharmacokinetic parameters of the prodrug stimulant lisdexamfetamine dimesylate via alternate routes of administration are limited. The pharmacokinetics of d-amphetamine derived from lisdexamfetamine dimesylate after single oral (PO) versus intranasal (IN) administration of lisdexamfetamine dimesylate were compared. Methods In this randomized, two-period, crossover study, healthy men without a history of substance abuse were administered single PO or IN (radiolabelled with ≤100 μCi (99m)Tc-diethylenetriamine-pentaacetic acid and confirmed by scintigraphy) lisdexamfetamine dimesylate 50 mg ≥7 days apart. Serial blood samples were drawn to measure d-amphetamine and intact lisdexamfetamine at 0 (pre-dose), 15, 30 and 45 minutes and at 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose for PO administration and at 0 (pre-dose), 5, 10, 15, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose for IN administration. Treatment-emergent adverse events (TEAEs) were assessed. Results Eighteen subjects were enrolled and completed the study. The mean ± SD maximum observed plasma concentration (C(max)) and area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUC(last)) of d-amphetamine following PO administration of lisdexamfetamine dimesylate were 37.6 ± 4.54 ng/mL and 719.1 ± 157.05 ng · h/mL, respectively; after IN administration, these parameters we…

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Crossref · 10.2165/11588190-000000000-00000

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28 of 28 references verified0 citation errors · 0 not checkable

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  • LDX was associated with predictable but modest increases in pulse and heart rate (both P < .05), beginning at week 2 and persisting through week 4, with no meaningful effects on ECG parameters such as PR, PP, and QT intervals.

    “Although LDX was associated with predictable but modest increases in pulse and heart rate (both, P < .05), beginning at week 2 and persisting through week 4, no meaningful effects on electrocardiogram (ECG) parameters such as PR, PP, and QT intervals were noted.”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [49]

  • In Adler et al safety data on cardiovascular parameters in 420 medically healthy adults with ADHD, no significant differences for mean systolic or diastolic blood pressure in any LDX dose group versus placebo were noted.

    “Safety data from the study by Adler et al49 of LDX on cardiovascular parameters in 420 medically healthy adults with ADHD were analyzed, and no significant differences for mean systolic or diastolic blood pressure in any LDX dose group vs placebo were noted.”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [49]

  • Oral and intranasal administration of lisdexamfetamine in healthy adult volunteers showed similar Cmax, area under the curve, and time to reach maximal concentration, with low intersubject variability and similar tolerability rates for both routes.

    “Oral and intranasal administration of lisdexamfetamine in healthy adult volunteers showed a similar Cmax, area under the curve, and time to reach maximal concentration, with low intersubject variability and similar tolerability rates for both routes of administration.16”

    From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [16]

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Authors
Ermer, J. C., Dennis, K., Haffey, M. B., Doll, W. J., Sandefer, E. P., Buckwalter, M., Page, R. C., Diehl, B., & Martin, P. T.
Affiliations
  • Takeda (United States) (US)
  • Jefferson Community and Technical College (US)
Corresponding author
Ermer, James C.
Venue
Clinical Drug Investigation
Publisher
Springer Science and Business Media LLC
Published
2011-06
Volume
31
Issue
6
Pages
357-370
ISSN
  • 0114-2402 (ISSN-L)
  • 1173-2563
DOI
10.2165/11588190-000000000-00000
OpenAlex
W777891328
Cited by
35
References
29
Citations by year
2025: 3 · 2023: 1 · 2022: 1 · 2021: 2 · 2020: 3 · 2018: 1 · 2017: 3 · 2016: 4 · 2015: 1 · 2014: 7 · 2013: 5 · 2012: 3
FWCI
5.39
Type
journal article
Language
en
Open access
closed
Locations
  • Clinical Drug Investigation (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Forensic Toxicology and Drug Analysis
Keywords
lisdexamfetamine dimesylate, intranasal administration, oral administration, pharmacokinetics, d-amphetamine, prodrugs, route of administration, treatment-emergent adverse events, stimulants, healthy volunteers, radiolabeled drug, 99mTc-DTPA scintigraphy, plasma concentration-time curve
MeSH terms
Lisdexamfetamine Dimesylate, Administration, Intranasal, Administration, Oral, Adolescent, Adult, Dextroamphetamine, Humans, Male, Middle Aged, Reference Values, Cross-Over Studies, Young Adult

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