Lisdexamfetamine Dimesylate: A Review in Paediatric ADHD
Abstract
Lisdexamfetamine dimesylate (lisdexamfetamine; Elvanse ® ; Tyvense ® ), an orally-active dexamfetamine prodrug, is indicated in the EU for the treatment of attention-deficit hyperactivity disorder (ADHD) in children aged ≥ 6 years (including adolescents) when the response to previous methylphenidate (MPH) treatment is clinically inadequate. The original approval of the drug was based on the results of phase III trials in children and adolescents with ADHD who had an inadequate response to previous pharmacotherapy (e.g. MPH) or were treatment naïve. In these studies, short-term treatment with flexibly-dosed lisdexamfetamine demonstrated greater efficacy than atomoxetine, based on a prospective comparison, and osmotic-release oral system (OROS)-MPH, based on a post hoc comparison. Improvements in ADHD symptoms were accompanied by improvements in health-related quality of life and functioning that were maintained as long as treatment with lisdexamfetamine was continued in a long-term extension of one of these trials. In subsequent phase IV head-to-head studies in adolescents with ADHD and an inadequate response to previous pharmacotherapy, lisdexamfetamine demonstrated greater efficacy than OROS-MPH when both medications were force-titrated, but not when they were flexibly-titrated. Lisdexamfetamine was generally well tolerated, with an adverse event profile (e.g. decreased appetite, headache, weight reduction, insomnia and irritability) typical of that reported for other stimul…
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LDX is indicated and recommended by guidelines in children at least 6 years of age when MPH treatment is not optimal, and as first-line treatment in adults and for binge eating disorder in the USA.
“LDX is the first stimulant prodrug indicated and recommended by guidelines in children at least 6 years of age when the MPH treatment is not optimal [132, 150], and also as first-line treatment in adults [133, 151] and for binge eating disorder [40] in the USA.”
From Molecular Characterisation of the Mechanism of Action of Stimulant Drugs Lisdexamfetamine and Methylphenidate on ADHD Neurobiology: A Review (2022) · cites this paper as [150]
Cites
Absorption of lisdexamfetamine dimesylate and its enzymatic conversion to d-amphetamine
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“The absorption of lisdexamfetamine is thought to involve a high-capacity system (peptide transporter 1 in the small intestine); the rate-limiting step of its conversion to d-amfetamine (primarily by red blood cells) also appears to involve a high-capacity system [22].”
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Lisdexamfetamine Dimesylate: A New Therapeutic Option for Attention-Deficit Hyperactivity Disorder
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Quintero, J., Gutiérrez-Casares, J. R., & Álamo, C. (2022) · Neurology and Therapy · doi:10.1007/s40120-022-00392-2 · Cited by 70 · see citing works
“LDX is the first stimulant prodrug indicated and recommended by guidelines in children at least 6 years of age when the MPH treatment is not optimal [132, 150], and also as first-line treatment in adults [133, 151] and for binge eating disorder [40] in the USA.”
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Ikeda, T., Inoue, A., Tanaka, D., Hashimoto, T., Sutoko, S., Tokuda, T., Kyutoku, Y., Maki, A., Yamagata, T., Dan, I., et al. (2021) · Frontiers in Neuroergonomics · doi:10.3389/fnrgo.2021.657657 · Cited by 7 · see citing works
- Authors
- Frampton, J. E.
- Affiliations
- Springer Nature (New Zealand) (NZ)
- Corresponding author
- Frampton, James E.
- ORCID
- Frampton, James E.
- Venue
- Drugs
- Published
- 2018-06-19
- Volume
- 78
- Issue
- 10
- Pages
- 1025-1036
- ISSN
- 0012-6667 (ISSN-L)
- 1179-1950
- OpenAlex
- W2809413551
- Cited by
- 34
- References
- 8
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 7 · 2023: 3 · 2022: 2 · 2021: 3 · 2020: 5 · 2019: 3 · 2018: 1 · 2017: 1
- FWCI
- 0.46
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Drugs (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, methylphenidate, OROS methylphenidate, atomoxetine, treatment-resistant ADHD, flexible dosing, head-to-head comparison, health-related quality of life, long-term treatment
- MeSH terms
- Lisdexamfetamine Dimesylate, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Dextroamphetamine, Dose-Response Relationship, Drug, Drug Administration Schedule, Europe, Humans, Methylphenidate, Quality of Life, Treatment Outcome, Drug Approval
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