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 |
|---|---|---|---|---|---|
2016/03/18 | Phase 4 | Completed | |||
2016/02/05 | Phase 4 | Completed | |||
2016/01/29 | Phase 1 | Completed | University Hospital, Basel, Switzerland | ||
2016/01/20 | Phase 2 | UNKNOWN | Lindner Center of HOPE | ||
2015/12/18 | Phase 2 | Completed | |||
2015/09/21 | Phase 3 | Completed | |||
2015/06/09 | Phase 3 | Completed | |||
2015/03/30 | Phase 2 | Completed | |||
2014/10/08 | Not Applicable | Terminated | |||
2014/06/23 | Phase 4 | Terminated |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ascent Pharmaceuticals, Inc. | 43602-307 | ORAL | 20 mg in 1 1 | 8/28/2023 | |
| Apotex Corp. | 60505-4742 | ORAL | 40 mg in 1 1 | 12/20/2023 | |
| Sun Pharmaceutical Industries, Inc. | 57664-087 | ORAL | 50 mg in 1 1 | 12/1/2023 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0375 | ORAL | 70 mg in 1 1 | 1/19/2024 | |
| Sun Pharmaceutical Industries, Inc. | 57664-047 | ORAL | 20 mg in 1 1 | 12/1/2023 | |
| Alvogen Inc. | 47781-564 | ORAL | 30 mg in 1 1 | 6/30/2022 | |
| Sun Pharmaceutical Industries, Inc. | 57664-046 | ORAL | 10 mg in 1 1 | 12/1/2023 | |
| Lannett Company, Inc. | 0527-4666 | ORAL | 60 mg in 1 1 | 10/20/2023 | |
| Sun Pharmaceutical Industries, Inc. | 57664-051 | ORAL | 60 mg in 1 1 | 12/1/2023 | |
| Solco Healthcare US,LLC | 43547-604 | ORAL | 30 mg in 1 1 | 3/31/2023 |
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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