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Lisdexamfetamine Dimesylate: A Review in Paediatric ADHD

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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 stimulants. Thus, lisdexamfetamine provides an alternative option for the treatment of children and/or adolescents with ADHD who have not responded adequately to previous ADHD pharmacotherapies.

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Acknowledgements

During the peer review process, the manufacturer of lisdexamfetamine was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    James E. Frampton

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  1. James E. Frampton
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Correspondence to James E. Frampton.

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The preparation of this review was not supported by any external funding.

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James Frampton is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: D.R. Coghill, Department of Paediatrics, Faculty of Medicine, Dentistry and Health Science, University of Melbourne, Melbourne, Australia; S. Cortese, Centre for Innovation in Mental Health, Academic Unit of Psychology, University of Southampton, Southampton, UK; R. Jain, Department of Psychiatry, Texas Tech Health Sciences Center School of Medicine, Midland, TX, USA; M. Johnson, Gillberg Neuropsychiatry Center, University of Gothenburg, Gothenburg, Sweden; J. Najib, LIU, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Brooklyn, NY, USA; C.R. Steer, Paediatric Department, Victoria Hospital, Kirkcaldy, UK.

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Frampton, J.E. Lisdexamfetamine Dimesylate: A Review in Paediatric ADHD. Drugs 78, 1025–1036 (2018). https://doi.org/10.1007/s40265-018-0936-0

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