Amphetamine

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

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Title	Posted	Study ID	Phase	Status	Sponsor
Caffeine and Cocaine	2008/08/13	NCT00733993	Phase 1	Completed	Virginia Commonwealth University
Neurobiological Principles Applied to the Rehabilitation of Stroke Patients	2008/07/15	NCT00715520	Not Applicable	Completed	Emory University
ADDERALL XR (Mixed Salts of a Single-entity Amphetamine) and STRATTERA ( Atomoxetine Hydrochloride) Compared to Placebo on Simulated Driving Safety and Performance and Cognitive Functioning in Adults With ADHD	2007/11/14	NCT00557960	Phase 3	Completed	Shire
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD	2007/11/12	NCT00557011	Phase 2	Completed	New River Pharmaceuticals
A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall	2007/05/02	NCT00468143	Phase 4	Completed	NYU Langone Health
Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder	2005/09/28	NCT00228046	Phase 4	Completed	Stony Brook University
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)	2005/09/09	NCT00151996	Phase 2	Completed	Shire

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	Lannett Company, Inc.	0527-5513	ORAL	5.0 mg in 1 1	12/18/2019
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Teva Pharmaceuticals USA, Inc.	0555-0972	ORAL	2.5 mg in 1 1	8/1/2023
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE	Bryant Ranch Prepack	63629-2378	ORAL	3.75 mg in 1 1	7/24/2017
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE	Camber Pharmaceuticals, Inc.	31722-187	ORAL	3.75 mg in 1 1	10/21/2021
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate	Bryant Ranch Prepack	63629-9486	ORAL	1.875 mg in 1 1	3/2/2022
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	Zydus Pharmaceuticals (USA) Inc.	70710-1185	ORAL	2.5 mg in 1 1	12/17/2021
Amphetamine Sulfate	Aurolife Pharma, LLC	13107-259	ORAL	5 mg in 1 1	1/31/2024
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE	Camber Pharmaceuticals, Inc.	31722-157	ORAL	2.5 mg in 1 1	9/28/2023
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate	NorthStar RxLLC	16714-954	ORAL	7.5 mg in 1 1	2/9/2023
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate	ANI Pharmaceuticals, Inc.	43975-281	ORAL	6.25 mg in 1 1	10/31/2023

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
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NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
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PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
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TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
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