Overview
Amphetamine, a compound discovered over 100 years ago, is one of the more restricted controlled drugs. It was previously used for a large variety of conditions and this changed until this point where its use is highly restricted. Amphetamine, with the chemical formula alpha-methylphenethylamine, was discovered in 1910 and first synthesized by 1927. After being proven to reduce drug-induced anesthesia and produce arousal and insomnia, amphetamine racemic mix was registered by Smith, Kline and French in 1935. Amphetamine structure presents one chiral center and it exists in the form of dextro- and levo-isomers. The first product of Smith, Kline and French was approved by the FDA on 1976. During World War II, amphetamine was used to promote wakefulness in the soldiers. This use derived into a large overproduction of amphetamine and all the surplus after the war finalized ended up in the black market, producing the initiation of the illicit abuse.
Indication
Amphetamine is indicated for the treatment of attention-deficit/hyperactivity disorders (ADHD) as well as for the treatment of central nervous system disorders such as narcolepsy. ADHD is a complex disorder associated with the substantial heterogeneity in etiology, clinical presentation, and treatment outcome. ADHD comes from a complex interplay between interdependent genetic and non-genetic factors which cause complex mental disorders in children and teenagers. On the other hand, narcolepsy is a chronic sleep disorder typically resenting during adolescence and characterized by excessive daytime sleepiness. Amphetamine is also being used nowadays off-label for the treatment of obesity, depression and chronic pain.
Associated Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Chronic Pain
- Depression
- Narcolepsy
- Obesity
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/03 | Phase 4 | Not yet recruiting | Gagan Joshi | ||
2024/02/08 | Phase 4 | Recruiting | |||
2020/11/19 | Phase 4 | Withdrawn | |||
2020/01/22 | Phase 2 | Active, not recruiting | |||
2019/11/20 | Phase 4 | Completed | Jeffrey Newcorn | ||
2019/10/21 | N/A | Completed | |||
2019/07/22 | Phase 2 | Completed | |||
2019/05/10 | Phase 3 | Completed | |||
2019/05/02 | Phase 2 | Recruiting | |||
2019/03/27 | Phase 2 | UNKNOWN | United States Army Aeromedical Research Laboratory |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Global Pharmaceuticals, Division of Impax Laboratories Inc. | 0115-1333 | ORAL | 7.5 mg in 1 1 | 5/14/2015 | |
| Bryant Ranch Prepack | 72162-2056 | ORAL | 2.5 mg in 1 1 | 7/14/2023 | |
| Granules Pharmaceuticals Inc. | 70010-031 | ORAL | 3.75 mg in 1 1 | 11/11/2023 | |
| Takeda Pharmaceuticals America, Inc. | 54092-387 | ORAL | 5 mg in 1 1 | 10/25/2023 | |
| Granules Pharmaceuticals Inc. | 70010-041 | ORAL | 10 mg in 1 1 | 10/16/2023 | |
| Lannett Company, Inc. | 0527-1504 | ORAL | 3.750 mg in 1 1 | 2/15/2019 | |
| Actavis Pharma, Inc. | 0228-3059 | ORAL | 2.5 mg in 1 1 | 2/9/2024 | |
| AZURITY PHARMACEUTICALS, INC. | 24338-022 | ORAL | 5 mg in 1 1 | 10/26/2023 | |
| Lannett Company, Inc. | 0527-2525 | ORAL | 10 mg in 1 1 | 1/19/2024 | |
| Bryant Ranch Prepack | 63629-2382 | ORAL | 5 mg in 1 1 | 7/24/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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