CLINICAL TRIALS PROFILE FOR ADDERALL 10

505(b)(2) Clinical Trials for Adderall 10

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
OTC	NCT00746733 ↗	Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC	Completed	Shire	Phase 1	2008-09-08	The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.

All Clinical Trials for Adderall 10

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	National Cancer Institute (NCI)	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00069927 ↗	Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression	Terminated	University of South Florida	Phase 2	2003-08-01	RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression. PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
NCT00247572 ↗	Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories	Completed	New River Pharmaceuticals	Phase 2	2005-09-01	This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to learn if NRP104, when injected into a vein, produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.
NCT00248092 ↗	Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse	Completed	New River Pharmaceuticals	Phase 1/Phase 2	2006-01-01	This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to learn if NRP104 produces a high and any other effects like amphetamine and other stimulant drugs that are abused. This information will give some indication if NRP104 can be abused. NRP104 is an investigational drug. This means that it has not been approved by the U.S. Food and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to treat narcolepsy (excessive sleepiness) and for weight loss.

Clinical Trial Conditions for Adderall 10

Condition Name

Condition Name for Adderall 10
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
ADHD	3
Cocaine Dependence	3

Condition MeSH

Condition MeSH for Adderall 10
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	22
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for Adderall 10

Trials by Country

Trials by Country for Adderall 10
Location	Trials
United States	38
Canada	6

Trials by US State

Trials by US State for Adderall 10
Location	Trials
New York	9
Massachusetts	6
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for Adderall 10

Clinical Trial Phase

Clinical Trial Phase for Adderall 10
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Adderall 10
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for Adderall 10

Sponsor Name

Sponsor Name for Adderall 10
Sponsor	Trials
Shire	7
New York State Psychiatric Institute	5
National Institute on Drug Abuse (NIDA)	5

Sponsor Type

Sponsor Type for Adderall 10
Sponsor	Trials
Other	44
Industry	13
NIH	8

Adderall: Clinical Trials, Market Analysis, and Projections

Introduction

Adderall, a medication primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy, has been a significant player in the pharmaceutical market. This article will delve into the current clinical trials, market analysis, and future projections for Adderall.

Clinical Trials Update

Psychostimulant Augmentation of Repetitive TMS for Depression

One notable clinical trial involving Adderall is the "Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder" study. Conducted by the University of California, this Phase 1 interventional study aims to evaluate the effects of Adderall XR (amphetamine) when combined with repetitive Transcranial Magnetic Stimulation (rTMS) for treating treatment-resistant major depressive disorder.

• Study Design: Participants are randomly assigned to either an active group receiving 15 mg of Adderall XR daily or a placebo group. The study drug is initiated at least 10 days before rTMS treatment to assess side effects and establish stable mood.
• Outcome Measures: The primary outcome measure is the IDS-SR30 score, which monitors treatment outcomes. Patients must exhibit stable mood before initiating rTMS to isolate the effect of Adderall XR on rTMS response[1].

Market Analysis

Market Size and Growth Projections

The global Adderall market is experiencing significant growth driven by several factors:

• Increasing Prevalence of ADHD: The rising global prevalence of ADHD, particularly in the U.S., where about 6 million children aged 3 to 17 have been diagnosed, is a major driver. Approximately 62% of these children take medication to manage their symptoms[2][5].
• Growing Awareness and Healthcare Expenditure: Increased awareness among healthcare professionals and patients, along with escalating healthcare expenditure, contribute to market growth[2].

The Adderall market was estimated at USD 20.90 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4% from 2024 to 2032, reaching a value of about USD 29.75 billion by 2032[5].

Regional Market Dynamics

• North America: This region dominates the Adderall market due to high awareness, rising disease prevalence, and advanced healthcare infrastructure. The U.S. alone accounted for 69.1% of the global ADHD market revenue in 2023[2].
• Europe and Asia Pacific: These regions are also significant, with Europe showing steady growth and the Asia Pacific region expected to grow at the highest CAGR during the forecast period due to increasing awareness and healthcare expenditure[2].

Drug Type and Usage

• Stimulant Segment: Adderall, being part of the stimulant segment, accounted for 70.91% of the ADHD market share in 2023 due to its high prescription and usage rates. It is available in both immediate-release and extended-release formulations, catering to different patient needs[2].

Price Trends and Challenges

Price Increases and Shortages

The Adderall market has faced significant price increases and shortages:

• Price Fluctuations: Prices have nearly doubled or tripled for certain dosages since the Adderall shortage began in October 2022. For example, the price of Adderall XR 10mg increased dramatically from $10 to $158 over a few months[2].
• Supply and Demand Imbalance: The ongoing shortage, attributed to manufacturing delays and worker shortages, has led to a supply and demand imbalance, resulting in higher prices. Patients are being advised to consider alternative ADHD medications due to this shortage[2].

Key Players and Market Competition

The Adderall market is highly competitive with several key players:

• Major Players: Companies such as Novartis AG, Eli Lilly and Company, Johnson & Johnson Services, Inc., Lupin, and Takeda Pharmaceutical Company Limited are focusing on developing new drugs and therapies to strengthen their market position[2].

Regulatory Environment

Adderall is a controlled substance, highly regulated by the U.S. government:

• DEA Regulations: The Drug Enforcement Administration (DEA) maintains strict rules on maximum production to avoid patient abuse, which can impact supply and pricing[2].

Patient and Healthcare Provider Perspectives

• Cost Concerns: Significant price increases have become a major concern for patients and their families. Insurance coverage and financial assistance programs play crucial roles in managing these costs[2].
• Alternative Solutions: Healthcare providers are working with patients to find alternative medications and utilizing manufacturer coupons and other financial assistance programs to make treatments more affordable[2].

Future Outlook

Despite current challenges, the Adderall market is expected to continue its growth trajectory:

• Recovery in Supply Chain: The post-pandemic period is anticipated to see a recovery in supply chain and manufacturing activities, driven by increasing demand for effective ADHD treatments[2].
• New Pipeline Agents: Four late-stage pipeline agents targeting core ADHD symptoms are expected to launch in the U.S. market by 2026, which may drive moderate market growth[3].

Key Takeaways

• Growing Market: The global Adderall market is growing due to increasing ADHD prevalence and awareness.
• Regional Dominance: North America dominates the market, with Europe and the Asia Pacific region also showing significant growth.
• Price and Supply Challenges: Price increases and shortages are current challenges, but the market is expected to recover and grow in the future.
• Regulatory and Patient Affordability: Regulatory environments and patient affordability remain critical factors.
• New Developments: Key players are focusing on new drug developments and therapies, and new pipeline agents are expected to launch soon.

FAQs

What is the current status of the clinical trial involving Adderall and rTMS for depression?

The clinical trial is ongoing, with participants randomly assigned to either an active group receiving Adderall XR or a placebo group. The study aims to evaluate the effects of Adderall XR when combined with rTMS for treating treatment-resistant major depressive disorder[1].

How is the global Adderall market expected to grow?

The global Adderall market is projected to grow at a CAGR of 4% from 2024 to 2032, reaching a value of about USD 29.75 billion by 2032[5].

What are the main drivers of the Adderall market growth?

The main drivers include the increasing prevalence of ADHD, growing awareness among healthcare professionals and patients, and escalating healthcare expenditure[2].

Why are there price increases and shortages in the Adderall market?

The ongoing shortage, attributed to manufacturing delays and worker shortages, has led to a supply and demand imbalance, resulting in higher prices. Patients are being advised to consider alternative ADHD medications due to this shortage[2].

Who are the key players in the Adderall market?

Key players include Novartis AG, Eli Lilly and Company, Johnson & Johnson Services, Inc., Lupin, and Takeda Pharmaceutical Company Limited[2].

What is the regulatory environment like for Adderall?

Adderall is a controlled substance, highly regulated by the U.S. government. The DEA maintains strict rules on maximum production to avoid patient abuse, which can impact supply and pricing[2].

Sources

1. University of California Health: Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder, ClinicalTrials.gov.
2. DrugPatentWatch: Market Analysis and Price Projections for Adderall.
3. Clinical Trials Arena: 7MM ADHD market forecast to decline by $1bn between 2022 and 2032.
4. Biospace: Shire Pharmaceuticals Group plc Announces Positive Results Of Two-Year Study Of Adderall XR In The Treatment Of Adult ADHD.
5. Expert Market Research: Adderall Drug Market Size, Share | Industry Statistics 2034.