CLINICAL TRIALS PROFILE FOR ADDERALL XR 25

505(b)(2) Clinical Trials for Adderall Xr 25

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 Xr 25

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.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	Bristol-Myers Squibb	Phase 2	2006-07-01	The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.

Clinical Trial Conditions for Adderall Xr 25

Condition Name

Condition Name for Adderall Xr 25
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
Major Depressive Disorder	3
ADHD	3

Condition MeSH

Condition MeSH for Adderall Xr 25
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	22
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for Adderall Xr 25

Trials by Country

Trials by Country for Adderall Xr 25
Location	Trials
United States	38
Canada	6

Trials by US State

Trials by US State for Adderall Xr 25
Location	Trials
New York	9
Massachusetts	6
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for Adderall Xr 25

Clinical Trial Phase

Clinical Trial Phase for Adderall Xr 25
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Adderall Xr 25
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for Adderall Xr 25

Sponsor Name

Sponsor Name for Adderall Xr 25
Sponsor	Trials
Shire	7
New York State Psychiatric Institute	5
National Institute on Drug Abuse (NIDA)	5

Sponsor Type

Sponsor Type for Adderall Xr 25
Sponsor	Trials
Other	44
Industry	13
NIH	8

Adderall XR: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy of Adderall XR

Trial Duration and Outcomes

Clinical trials for Adderall XR, an extended-release formulation of mixed amphetamine salts, have primarily been short-term, lasting no more than four weeks. These trials have shown significant improvements in behavioral symptoms and academic performance compared to placebo and other medications like atomoxetine.

• Children and Adolescents: In trials involving children and adolescents, Adderall XR significantly reduced behavioral symptoms as measured by the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) deportment and attention subscales. It also improved performance on the 10-minute math test and resulted in a higher proportion of participants achieving clinical improvement on the Clinical Global Impression Improvement Scale (CGI-I)[1].

• Adults: Similar improvements were observed in adult trials, with Adderall XR showing better outcomes in deportment, attention, and math test performance compared to placebo[1].

Limitations and Concerns

Despite these short-term benefits, there are several limitations and concerns:

• Lack of Long-Term Trials: There is a significant lack of long-term randomized trials to determine whether these short-term improvements translate into clinically important outcomes such as quality of life, academic performance, and behavioral outcomes over an extended period[1].
• Cost-Effectiveness: Adderall XR has not been shown to be cost-effective as a first-line therapy or for patients who have not achieved adequate control with other stimulant agents like methylphenidate or dexamphetamine[1].

Adverse Events

The trials also highlighted common adverse events associated with Adderall XR, including decreased appetite, insomnia, and potentially adverse cardiovascular effects such as elevated blood pressure and increased pulse. However, the rate of withdrawal due to adverse events was not significantly different from other medications like atomoxetine[1].

Market Analysis for Adderall XR

Market Size and Growth Projections

The global market for ADHD medications, including Adderall XR, is experiencing substantial growth.

• Global Market Value: The global ADHD market was estimated at USD 14.3 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.7% from 2024 to 2030, reaching USD 18.6 billion by 2030. Specifically, the Adderall market is expected to grow at a CAGR of 4% from 2023 to 2031, potentially reaching USD 28.61 billion by 2031[2].

Regional Dynamics

• North America: This region dominates the Adderall market due to high awareness among healthcare professionals, 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: Europe is a significant market with key players and increasing investment in research and development. The Asia Pacific region is expected to grow at the highest CAGR during the forecast period due to increasing awareness about ADHD and rising healthcare expenditure[2].

Drug Type and Usage

• Stimulant Segment: The stimulant segment, which includes Adderall XR, accounted for 70.91% of the ADHD market share in 2023 due to its high prescription and usage rates. Stimulants are preferred for their efficacy and immediate results[2].
• Formulations: Adderall XR is available in various strengths (5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules), catering to different patient needs based on symptom severity and response to the medication[3].

Price Trends and Challenges

Price Increases and Shortages

• Price Fluctuations: There has been a significant increase in the prices of ADHD medications, including Adderall XR, particularly 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].

Impact of Shortages

• Alternative Medications: Patients are being directed towards alternative ADHD medications such as Ritalin, Concerta, and Strattera due to the ongoing shortage of Adderall XR[2].

Generic Versions and Market Competition

Generic Adderall XR

• Market Entry: Lannett Company, Inc. began marketing a generic version of Adderall XR in 2020, offering capsules in various strengths. This move aims to provide more affordable options for patients, although the actual generic market values are expected to be lower than the branded version[3].

Key Players

• Competitive Landscape: The Adderall market is highly competitive with several key players, including Novartis AG, Eli Lilly and Company, Johnson & Johnson Services, Inc., Lupin, Takeda Pharmaceutical Company Limited, and others. These companies are focusing on developing new drugs and therapies to strengthen their market position[2].

Regulatory Environment

Controlled Substance

• DEA Regulations: Adderall XR is a controlled substance, highly regulated by the U.S. government. The Drug Enforcement Administration (DEA) maintains strict rules on maximum production to avoid patient abuse, which can impact supply and pricing[2].

Key Takeaways

• Clinical Efficacy: Adderall XR has shown significant short-term improvements in behavioral symptoms and academic performance but lacks long-term trial data.
• Market Growth: The global ADHD market, including Adderall XR, is projected to grow substantially, driven by increasing prevalence and awareness.
• Price and Supply Issues: The ongoing shortage has led to significant price increases and a supply and demand imbalance.
• Generic Options: Generic versions of Adderall XR are available, offering more affordable alternatives.
• Regulatory Oversight: Strict DEA regulations impact the supply and pricing of Adderall XR.

FAQs

What are the primary benefits of Adderall XR in clinical trials?

Adderall XR has shown significant improvements in behavioral symptoms and academic performance in short-term trials, particularly in children and adolescents.

Why is there concern about the long-term efficacy of Adderall XR?

There is a lack of long-term randomized trials to determine whether the short-term benefits translate into clinically important outcomes such as quality of life, academic performance, and behavioral outcomes.

What is the current market size and growth projection for Adderall XR?

The global ADHD market, including Adderall XR, was estimated at USD 14.3 billion in 2023 and is projected to grow at a CAGR of 3.7% to USD 18.6 billion by 2030. The Adderall market specifically is expected to grow at a CAGR of 4% to USD 28.61 billion by 2031.

What are the main factors driving the growth of the Adderall market?

The growth is driven by increasing prevalence of ADHD, growing awareness among healthcare professionals and patients, and escalating healthcare expenditure.

How has the shortage of Adderall XR affected its pricing?

The ongoing shortage has led to significant price increases due to a supply and demand imbalance, with prices nearly doubling or tripling for certain dosages.

Are there generic versions of Adderall XR available?

Yes, generic versions of Adderall XR are available, marketed by companies like Lannett Company, Inc., offering more affordable options for patients.

Sources

1. Mixed Amphetamine Salts Adderall XR® – Shire Canada Inc. - Common Drug Review.
2. Market Analysis and Price Projections for Adderall - DrugPatentWatch.
3. Lannett Begins Marketing Generic Adderall® XR - BioSpace.
4. Attention Deficit Hyperactivity Disorder (ADHD) Market Spotlight - BusinessWire.
5. A review of amphetamine extended release once-daily options for ADHD - Taylor & Francis Online.