Lisdexamfetamine

Overview

Lisdexamfetamine is a prodrug of dextroamphetamine, a central nervous system stimulant known as d-amphetamine, covalently attached to the naturally occurring amino acid L-lysine. Lisdexamfetamine is the first chemically formulated prodrug stimulant and was first approved by the FDA in April 2008. It was also approved by Health Canada in February 2009. Lisdexamfetamine works to treat attention deficit hyperactivity disorder and binge eating disorder by blocking dopamine and norepinephrine reuptake and increasing their levels in the extraneuronal space.

Indication

Lisdexamfetamine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients six years and older. It is also indicated to treat moderate to severe binge eating disorder (BED) in adults. It is approved for use in the US and Canada.

Associated Conditions

Attention Deficit Hyperactivity Disorder (ADHD)
Moderate Binge Eating Disorder (BED)
Severe Binge Eating Disorder (BED)

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)	2007/07/12	NCT00500149	Phase 3	Completed	Shire
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD	2007/07/12	NCT00500071	Phase 4	Completed	Shire
An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)	2006/06/15	NCT00337285	Phase 3	Completed	New River Pharmaceuticals
Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)	2006/06/08	NCT00334880	Phase 3	Completed	New River Pharmaceuticals
Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse	2005/11/03	NCT00248092	Phase 1	Completed	New River Pharmaceuticals
Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories	2005/11/02	NCT00247572	Phase 2	Completed	New River Pharmaceuticals

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
lisdexamfetamine dimesylate	Alvogen Inc.	47781-568	ORAL	70 mg in 1 1	6/30/2022
Vyvanse	Takeda Pharmaceuticals America, Inc.	59417-120	ORAL	60 mg in 1 1	10/13/2023
lisdexamfetamine dimesylate	Alvogen Inc.	47781-567	ORAL	60 mg in 1 1	6/30/2022
Lisdexamfetamine Dimesylate	Hikma Pharmaceuticals USA Inc.	0054-0372	ORAL	40 mg in 1 1	1/19/2024
LISDEXAMFETAMINE DIMESYLATE	Rhodes Pharmaceuticals	42858-165	ORAL	50 mg in 1 1	10/31/2023
Lisdexamfetamine Dimesylate	Mylan Pharmaceuticals Inc.	0378-6860	ORAL	70 mg in 1 1	12/12/2022
LISDEXAMFETAMINE DIMESYLATE	Sun Pharmaceutical Industries, Inc.	57664-085	ORAL	30 mg in 1 1	12/1/2023
Lisdexamfetamine Dimesylate	Amneal Pharmaceuticals LLC	65162-024	ORAL	30 mg in 1 1	1/17/2024
Lisdexamfetamine dimesylate	Solco Healthcare US,LLC	43547-607	ORAL	60 mg in 1 1	3/31/2023
Vyvanse	Takeda Pharmaceuticals America, Inc.	59417-104	ORAL	40 mg in 1 1	10/13/2023

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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