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Lisdexamfetamine Dimesylate: Prodrug Delivery, Amphetamine Exposure and Duration of Efficacy

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Ermer, James C., Pennick, Michael, Frick, Glen·2016·Clinical Drug Investigation
DOI 10.1007/s40261-015-0354-yPMC PMC4823324
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Abstract

Lisdexamfetamine dimesylate (LDX) is a long-acting d-amphetamine prodrug used to treat attention-deficit/hyperactivity disorder (ADHD) in children, adolescents and adults. LDX is hydrolysed in the blood to yield d-amphetamine, and the pharmacokinetic profile of d-amphetamine following oral administration of LDX has a lower maximum plasma concentration (Cmax), extended time to Cmax (Tmax) and lower inter- and intra-individual variability in exposure compared with the pharmacokinetic profile of an equivalent dose of immediate-release (IR) d-amphetamine. The therapeutic action of LDX extends to at least 13 h post-dose in children and 14 h post-dose in adults, longer than that reported for any other long-acting formulation. Drug-liking scores for LDX are lower than for an equivalent dose of IR d-amphetamine, which may result from the reduced euphorigenic potential associated with its pharmacokinetic profile. These pharmacokinetic and pharmacodynamic characteristics of LDX may be beneficial in the management of symptoms in children, adolescents and adults with ADHD.

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  • LDX is not metabolized by cytochrome P450 enzymes and is unlikely to be involved in drug interactions involving CYP enzymes or P-glycoprotein; however, it is contraindicated during or within 2 weeks following administration of monoamine oxidase inhibitors.

    “Lisdexamfetamine dimesylate is not metabolized by cytochrome P450 enzymes and unlikely to be involved in drug interactions involving CYP enzymes or P-glycoprotein; however, it is contraindicated during or within 2 weeks following the administration of monoamine oxidase inhibitors.”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [16]

    Split into 2 atoms — 1 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured

  • No histopathologic changes have been noted in any studies with LDX, and toxicology findings are unremarkable and consistent with changes in behavioral activity associated with stimulant exposure, as is loss of appetite and reductions in weight gain and growth measurements.

    “No histopathologic changes have been noted in any studies with LDX, and findings regarding toxicology are unremarkable and consistent with changes in behavioral activity associated with stimulant exposure, as is loss of appetite and reductions in weight gain and growth measurements.16”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [16]

    Split into 2 atoms — 0 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.

    Experimental — accuracy not yet measured

  • As d-amphetamine is released slowly from the prodrug LDX, it does not produce the subjective "rush" experienced by drug abusers and may offer reduced abuse potential relative to immediate-release d-amphetamine.

    “As d-amphetamine is released slowly from the prodrug LDX, it does not produce the subjective “rush” experienced by drug abusers and may offer reduced abuse potential relative to immediate-release d-amphetamine.16”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [16]

    The Conclusions and Safety sections report slower d-amphetamine exposure, lower drug-liking scores at equivalent doses, and a possible reduction in abuse potential compared with immediate-release d-amphetamine. They do not support the categorical statement that LDX produces no subjective “rush”: the Safety section reports significant drug-liking at a supratherapeutic LDX dose. Page numbers are not available in our copy. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • Lisdexamfetamine shows lower inter- and intra-individual variability in exposure compared with an equivalent dose of immediate-release d-amphetamine.

    “Such pharmacokinetic profile of lisdexamfetamine shows lower inter- and intra-individual variability in exposure compared with the pharmacokinetic profile of an equivalent dose of immediate-release d-amphetamine (22).”

    From Effects of Lisdexamfetamine, a Prodrug of D-Amphetamine, on Locomotion, Spatial Cognitive Processing and Neurochemical Profiles in Rats: A Comparison With Immediate-Release Amphetamine (2022) · cites this paper as [22]

  • Substantial hydrolysis of LDX occurs even at low hematocrit levels.

    “Substantial hydrolysis occurs even at low hematocrit levels”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [16]

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Cited by

Sorted by citations

Authors
Ermer, J. C., Pennick, M., & Frick, G.
Affiliations
  • Takeda (United States) (US)
  • University of Dundee (GB)
Corresponding author
Pennick, Michael
Venue
Clinical Drug Investigation
Publisher
Springer Science and Business Media LLC
Published
2016-03-28
Volume
36
Issue
5
Pages
341-356
ISSN
  • 0114-2402 (ISSN-L)
  • 1173-2563
  • 1179-1918
DOI
10.1007/s40261-015-0354-y
PMC
PMC4823324
OpenAlex
W2304244843
Cited by
67
References
16
Citations by year
2026: 6 · 2025: 14 · 2024: 12 · 2023: 5 · 2022: 7 · 2021: 6 · 2020: 5 · 2019: 3 · 2018: 5 · 2017: 4
FWCI
0.57
Type
journal article
Language
en
Open access
Licence
Locations
  • Clinical Drug Investigation (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Funders
Shire International GmbH
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
Keywords
lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, pharmacokinetics, drug liking, prodrug hydrolysis, children and adults
MeSH terms
Lisdexamfetamine Dimesylate, Administration, Oral, Adolescent, Adult, Amphetamine, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Humans, Male, Prodrugs, Drug Delivery Systems, Treatment Outcome

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