CLINICAL TRIALS PROFILE FOR AMPHETAMINE

505(b)(2) Clinical Trials for amphetamine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT01189214 ↗	Psychopharmacotherapy in Multiple Substances Abuse	Completed	National Institutes of Health (NIH)	Phase 3	2009-03-01	Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
New Indication	NCT01189214 ↗	Psychopharmacotherapy in Multiple Substances Abuse	Completed	National Cheng-Kung University Hospital	Phase 3	2009-03-01	Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
OTC	NCT01736332 ↗	Factors Affecting Methamphetamine and Opiates Drug Testing	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	2012-07-19	Background: - Some legal over-the-counter drugs (such as Vicks VapoInhaler ) and some foods (such as poppy seeds) may cause a positive screening drug test. This might look like someone used illegal drugs (such as methamphetamines or opiates) when they did not. Researchers are studying how the body handles chemicals that may test like illegal drugs and for how long they may be detected in the body. Blood, saliva, and urine samples will be collected. This study may help improve the effectiveness and accuracy of drug tests. Objectives: - To see how the body handles chemicals that may produce positive screening tests and how additional testing can eliminate positive drug tests from over-the-counter drugs and food. Eligibility: - Healthy volunteers between 18 and 65 years of age. Design: - Participants are screened with a physical exam, medical history, laboratory tests, and ECG. - This study involves an overnight stay on a secure research unit and 2 days of tests. - On the first day, participants will take Vicks VapoInhaler (two inhalations in each nostril) every 2 hours from 9 a.m. to 7 p.m. They will also take a drink containing poppy seeds twice (at about 9 a.m. and 5 p.m.). - On the morning of the second day, participants will take the Vicks VapoInhaler just once. They will be discharged around 5 p.m. - On both days, participants will provide blood and saliva samples several times throughout the day. All of their urine will be collected during the 2 study days....

All Clinical Trials for amphetamine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000305 ↗	Amphetamine Cocaine Interaction Study - 2	Terminated	National Institute on Drug Abuse (NIDA)	Phase 1	1969-12-31	The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.
NCT00000305 ↗	Amphetamine Cocaine Interaction Study - 2	Terminated	University of Texas	Phase 1	1969-12-31	The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.
NCT00000305 ↗	Amphetamine Cocaine Interaction Study - 2	Terminated	The University of Texas Health Science Center, Houston	Phase 1	1969-12-31	The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.

Clinical Trial Conditions for amphetamine

Condition Name

Condition Name for amphetamine
Intervention	Trials
Healthy	15
Attention Deficit Hyperactivity Disorder	13
Cocaine Dependence	9

Condition MeSH

Condition MeSH for amphetamine
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	36
Disease	29
Hyperkinesis	26

Clinical Trial Locations for amphetamine

Trials by Country

Trials by Country for amphetamine
Location	Trials
United States	140
Canada	14
Germany	12
France	6
Switzerland	6

Trials by US State

Trials by US State for amphetamine
Location	Trials
California	19
Texas	15
New York	14
Florida	11
Pennsylvania	7

Clinical Trial Progress for amphetamine

Clinical Trial Phase

Clinical Trial Phase for amphetamine
Clinical Trial Phase	Trials
Phase 4	33
Phase 3	16
Phase 2/Phase 3	9

Clinical Trial Status

Clinical Trial Status for amphetamine
Clinical Trial Phase	Trials
Completed	111
Recruiting	21
Terminated	10

Clinical Trial Sponsors for amphetamine

Sponsor Name

Sponsor Name for amphetamine
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	29
Shire	11
University of California, Los Angeles	9

Sponsor Type

Sponsor Type for amphetamine
Sponsor	Trials
Other	195
Industry	46
NIH	43

Amphetamine Market Analysis and Financial Projection

The Amphetamine Drug Market: Clinical Trials, Market Analysis, and Projections

Introduction

Amphetamine drugs, widely used for treating attention deficit hyperactivity disorder (ADHD), narcolepsy, and other conditions, are a significant segment of the pharmaceutical industry. This article delves into the current state of clinical trials, market analysis, and future projections for amphetamine drugs.

Clinical Trials Update

Recent Trials and Outcomes

One of the notable recent clinical trials involves Vallon Pharmaceuticals' ADAIR, an abuse-deterrent formulation of immediate-release dextroamphetamine designed to treat ADHD. The Phase III SEAL trial, however, failed to meet its primary endpoint, which was Emax Drug Liking. Although the trial did not achieve statistical significance, secondary endpoints showed promising results, with ADAIR scoring lower on Overall Drug Liking compared to reference dextroamphetamine[1].

Ongoing Studies

At the University of California Health, several clinical trials are underway to evaluate the effectiveness and safety of amphetamine medications. For instance, the AWARE study is examining the comparative effectiveness of methylphenidate and amphetamine in treating ADHD in children and adolescents with autism. This study uses a sequential, multiple assignment randomization trial (SMART) design to assess these medications and the role of alpha-2 agonists in ADHD treatment[4].

Another study, the Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS), aims to evaluate the pharmacokinetics (PK) of understudied drugs, including amphetamines, in children and young adults. This study is crucial for determining the safest and most effective doses for pediatric patients[4].

Market Analysis

Market Size and Growth Projections

The amphetamine drug market is expected to witness significant growth between 2025 and 2037, driven by increased research and development activities, government approvals, and a rise in central nervous system disorders, sleeping disorders, and depression cases. The market is anticipated to thrive due to a shift in consumer awareness regarding mental health and the support from governments to address these conditions[2][5].

Regional Analysis

North America is projected to hold the largest revenue share in the amphetamine drug market by 2037, primarily due to the high prevalence of depression and ADHD in this region. Europe is expected to be the second-largest market, driven by the presence of major pharmaceutical companies and increasing awareness about mental health. The Asia Pacific region is also expected to grow at a higher rate due to the increasing demand for drugs to treat various disorders[2].

Demographic Segmentation

The amphetamine drug market is segmented by demographics into children and adults. The adult segment is anticipated to hold the largest share, attributed to a larger adult patient population. However, the growing awareness of adult ADHD is expected to increase the number of treated cases across various regions[2].

Market Drivers and Challenges

Drivers

• Increased Research and Development: Continuous innovation and the approval of new drugs are driving market growth.
• Government Support: Governments are supporting the development and commercialization of ADHD drugs to address the rising number of cases.
• Growing Awareness: Increased consumer awareness about mental health is contributing to the market's expansion[2][5].

Challenges

• Patent Expiries: The expiration of patents for several branded ADHD products, such as Vyvanse, is expected to lead to a significant increase in generic competition, which could erode the sales of branded products[3].
• API Shortages: Shortages of active pharmaceutical ingredients (APIs) required for the manufacturing of generic products are affecting the market, though these are expected to be resolved by 2027[3].
• Hesitancy in Adopting New Products: Key opinion leaders (KOLs) have expressed hesitation in using new products due to the perception that they do not offer significant benefits over existing treatments[3].

Future Projections

Launch of New Pipeline Agents

Several late-stage pipeline agents are expected to launch in the US market between 2026 and 2032. These include Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR. These agents are anticipated to drive moderate market growth, competing against existing non-stimulant and long-acting methylphenidate products[3].

Market Value Forecast

Despite the launch of new pipeline agents and an expected increase in the patient population, the ADHD market across seven major markets (7MM) is forecast to decline by $1 billion from $11.9 billion in 2022 to $10.9 billion in 2032. This decline is primarily due to patent expiries and the high uptake of generic products[3].

Key Takeaways

• The amphetamine drug market is expected to grow driven by research, government support, and increasing awareness about mental health.
• Recent clinical trials, such as Vallon Pharmaceuticals' ADAIR, have shown mixed results but provide valuable insights into abuse-deterrent formulations.
• Ongoing studies at the University of California Health are focusing on the comparative effectiveness and safety of amphetamine medications.
• North America and Europe are expected to be the largest markets, with the Asia Pacific region showing significant growth potential.
• Patent expiries and API shortages are major challenges, but these are expected to be mitigated by 2027.
• New pipeline agents are anticipated to launch, but their adoption may be limited due to KOLs' hesitancy.

FAQs

What was the outcome of Vallon Pharmaceuticals' ADAIR clinical trial?

Vallon Pharmaceuticals' Phase III SEAL trial of ADAIR failed to meet its primary endpoint, Emax Drug Liking, although secondary endpoints showed promising results in reducing drug liking and willingness to take the drug again[1].

Which regions are expected to dominate the amphetamine drug market?

North America and Europe are anticipated to hold the largest market shares, with the Asia Pacific region expected to grow at a higher rate during the forecast period[2].

What are the main challenges facing the ADHD drug market?

The main challenges include patent expiries, shortages of active pharmaceutical ingredients (APIs), and hesitancy among key opinion leaders (KOLs) to adopt new products[3].

Are there any ongoing clinical trials for amphetamine drugs?

Yes, several clinical trials are ongoing, including the AWARE study and the POPS study at the University of California Health, which are examining the effectiveness and safety of amphetamine medications in various patient populations[4].

How is the ADHD market expected to change by 2032?

The ADHD market across 7MM is forecast to decline by $1 billion from $11.9 billion in 2022 to $10.9 billion in 2032, primarily due to patent expiries and the high uptake of generic products[3].

Sources

1. Biospace: "Vallon's Anti-Abuse ADHD Drug Formulation Flunks Clinical Trial"
2. Research Nester: "Amphetamine Drug Market Size & Share, Growth Analysis 2037"
3. Clinical Trials Arena: "7MM ADHD market forecast to decline by $1bn between 2022 and 2032"
4. University of California Health: "Amphetamines Clinical Trials for 2024"
5. Research Nester: "Amphetamine Drug Market Size - Research Nester"