CLINICAL TRIALS PROFILE FOR ADDERALL XR 10

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

Condition Name

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

Clinical Trial Locations for Adderall Xr 10

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Adderall Xr 10

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Adderall Xr 10
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Not yet recruiting	4

Clinical Trial Sponsors for Adderall Xr 10

Sponsor Name

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

Sponsor Type

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

Adderall XR 10 mg: Clinical Trials, Market Analysis, and Projections

Introduction

Adderall XR, a central nervous system (CNS) stimulant, is widely used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. This article will delve into the recent clinical trials, market analysis, and future projections for Adderall XR, particularly focusing on the 10 mg dosage.

Clinical Trials Update

Processing Speed in Multiple Sclerosis

A recent clinical trial has shown promising results for the use of Adderall XR in improving processing speed in patients with multiple sclerosis (MS). The study, which compared the effects of 10 mg and 20 mg of mixed amphetamine salt extended-release (MAS-XR) to a placebo, found that the 10 mg dose significantly improved performance on the Symbol Digit Modalities Test (SDMT), a reliable measure of processing speed in the MS population. The 10 mg dose resulted in an increase of 5.2 points on the SDMT compared to 0.6 points for the placebo group, with an effect size of 0.47[1].

ADHD and Narcolepsy

For its primary indications, Adderall XR has been extensively studied and approved since October 2001. Clinical trials have consistently shown its efficacy in improving symptoms of ADHD and managing narcolepsy. The drug's extended-release formulation provides a sustained therapeutic effect, making it a preferred option for many patients[3].

Market Analysis

Generic Versions

The market for Adderall XR has seen significant changes with the introduction of generic versions. Lannett Company, Inc. began marketing a generic version of Adderall XR in 2020, offering capsules in strengths of 5 mg to 30 mg. This move has increased competition and reduced costs for patients, making the medication more accessible[2][5].

Market Value

The estimated market value for Adderall XR and its generic versions is substantial, with an IQVIA market value of approximately $1.3 billion for the 12 months ending January 2020. However, the actual generic market values are expected to be lower due to increased competition[2].

Projections

Market Growth

The demand for ADHD medications is expected to continue growing due to increasing diagnoses and awareness of ADHD. With the availability of generic versions, the market for Adderall XR is likely to expand, making the medication more affordable for a broader patient base.

Competitive Landscape

The entry of multiple generic suppliers, including Lannett, Elite Pharmaceuticals, and SunGen Pharma, will continue to shape the market. This competition is expected to drive down prices and increase market penetration, benefiting patients and healthcare providers alike[2][5].

Safety and Adverse Reactions

Common Adverse Reactions

Clinical studies have identified common adverse reactions associated with Adderall XR, including loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever in pediatric patients. In adults, similar side effects are observed, with additional concerns such as motor and verbal tics, and the worsening of Tourette’s syndrome[4].

Risk-Benefit Assessment

The FDA has conducted thorough risk-benefit assessments, concluding that the benefits of Adderall XR outweigh the risks. No new safety signals have been identified in recent studies, supporting the continued use of this medication for its approved indications[3].

Key Takeaways

• Clinical Efficacy: Adderall XR 10 mg has shown significant improvement in processing speed in MS patients and remains effective for ADHD and narcolepsy.
• Market Competition: The introduction of generic versions has increased market competition, reducing costs and making the medication more accessible.
• Safety Profile: Common adverse reactions are well-documented, and the risk-benefit assessment supports the continued use of Adderall XR.
• Market Growth: The demand for ADHD medications is expected to grow, with the market for Adderall XR likely to expand due to increased affordability.

FAQs

What is Adderall XR used for?

Adderall XR is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy.

What are the common side effects of Adderall XR?

Common side effects include loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever.

Are there generic versions of Adderall XR available?

Yes, generic versions of Adderall XR are available, offered by companies such as Lannett, Elite Pharmaceuticals, and SunGen Pharma.

How does Adderall XR affect processing speed in MS patients?

A clinical trial found that 10 mg of Adderall XR significantly improved processing speed in MS patients, as measured by the Symbol Digit Modalities Test (SDMT).

What is the estimated market value of Adderall XR?

The estimated market value for Adderall XR and its generic versions is approximately $1.3 billion for the 12 months ending January 2020.

Sources

1. ClinicalTrials.Veeva: Adderall XR and Cognitive Impairment in MS.
2. BioSpace: Lannett Begins Marketing Generic Adderall® XR.
3. FDA: Adzenys Clinical Review.
4. FDA: Adderall XR Label.
5. BioSpace: Lannett To Commence Marketing Generic Adderall® XR.