CLINICAL TRIALS PROFILE FOR ADDERALL XR 5

505(b)(2) Clinical Trials for Adderall Xr 5

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 5

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.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	National Institute of Mental Health (NIMH)	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.
NCT00279409 ↗	Treatment of Children With ADHD Who do Not Fully Respond to Stimulants	Terminated	Otsuka Pharmaceutical Co., Ltd.	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 5

Condition Name

Condition Name for Adderall Xr 5
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
ADHD	3
Cocaine Dependence	3

Condition MeSH

Condition MeSH for Adderall Xr 5
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	22
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for Adderall Xr 5

Trials by Country

Trials by Country for Adderall Xr 5
Location	Trials
United States	38
Canada	6

Trials by US State

Trials by US State for Adderall Xr 5
Location	Trials
New York	9
Massachusetts	6
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for Adderall Xr 5

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Adderall Xr 5
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for Adderall Xr 5

Sponsor Name

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

Sponsor Type

Sponsor Type for Adderall Xr 5
Sponsor	Trials
Other	44
Industry	13
NIH	8

Adderall XR: Clinical Trials, Market Analysis, and Projections

Introduction to Adderall XR

Adderall XR, a mixed salts amphetamine product, is widely used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in both children and adults. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Long-Term Efficacy in ADHD

Clinical trials have consistently shown that Adderall XR is effective in managing ADHD symptoms over the long term. A Phase III study presented at the American Psychiatric Association Meeting revealed that adults with ADHD experienced significant symptom control when treated with Adderall XR. The 18-month interim analysis of a two-year extension study demonstrated that patients maintained a significant reduction in their ADHD symptoms, with improvements in focus, concentration, and attention[1].

Dose Optimization and Symptom Reduction

The study also highlighted the importance of dose optimization. Patients who switched from placebo to Adderall XR showed a significant improvement, with a 43% reduction in the ADHD-RS Inattention subscale and a 47% reduction in the ADHD-RS Hyperactive/Impulsive subscale. Once the optimal dose was determined, few patients required further adjustments, indicating stable efficacy over time[1].

Cognitive Improvement in Other Conditions

In addition to ADHD, Adderall XR has been studied for its effects on cognitive impairment in other conditions, such as Multiple Sclerosis (MS). A pre-post dose study found that a 10 mg dose of Adderall XR significantly improved performance on the Symbol Digit Modalities Test (SDMT), a measure of processing speed in the MS population[4].

Safety and Tolerability

Side Effects and Tolerability Profile

The safety profile of Adderall XR has been well-documented. The majority of side effects, such as dry mouth, loss of appetite, insomnia, and headache, are common for this class of medications and are generally mild or moderate. Most side effects occur in the first month of treatment and diminish over time[1].

Bioequivalence and Safety Studies

Bioequivalence studies, such as those conducted for Adzenys XR, have shown that generic versions of Adderall XR do not introduce new safety risks. These studies have confirmed that the generic formulations are as safe and effective as the brand name product[3].

Market Analysis

Market Presence and Generic Versions

Adderall XR has a strong market presence, and its popularity has led to the development of generic versions. Lannett Company, Inc., for example, has received FDA approval for a generic version of Adderall XR and has commenced marketing it. This move is expected to increase accessibility and reduce costs for patients[5].

User Reviews and Satisfaction

User reviews on platforms like Drugs.com indicate a high level of satisfaction with Adderall XR. With an average rating of 7.9 out of 10, 74% of reviewers reported a positive experience, citing improvements in focus, productivity, and overall quality of life[2].

Market Projections

Growing Demand for ADHD Treatments

The demand for ADHD treatments is expected to grow, driven by increasing awareness and diagnosis rates. As more adults seek treatment for ADHD, medications like Adderall XR are likely to see increased usage.

Competitive Landscape

The ADHD medication market is competitive, with several other stimulant and non-stimulant options available. However, Adderall XR's established efficacy and safety profile, along with the availability of generic versions, position it strongly in the market.

Future Developments

Future developments may include further studies on the use of Adderall XR in other conditions, such as cognitive impairment in MS, and ongoing postmarket risk evaluation and mitigation strategies to ensure continued safety.

Key Takeaways

• Efficacy: Adderall XR is highly effective in managing ADHD symptoms over the long term.
• Safety: The medication has a good tolerability profile, with most side effects being mild or moderate.
• Market Presence: Adderall XR has a strong market presence, with generic versions available to increase accessibility.
• User Satisfaction: High user satisfaction rates indicate significant improvements in quality of life.
• Future Projections: Growing demand for ADHD treatments and the competitive landscape suggest continued market relevance.

FAQs

Q: What is the primary use of Adderall XR?

A: Adderall XR is primarily used for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in both children and adults.

Q: How effective is Adderall XR in the long term?

A: Clinical trials have shown that Adderall XR maintains significant reductions in ADHD symptoms over long-term use, with improvements in focus, concentration, and attention[1].

Q: What are the common side effects of Adderall XR?

A: Common side effects include dry mouth, loss of appetite, insomnia, and headache, which are generally mild or moderate and diminish over time[1].

Q: Are generic versions of Adderall XR available?

A: Yes, generic versions of Adderall XR have been approved and are being marketed by companies like Lannett Company, Inc.[5].

Q: Can Adderall XR be used for conditions other than ADHD?

A: Yes, studies have explored the use of Adderall XR in other conditions, such as cognitive impairment in Multiple Sclerosis (MS), showing significant improvements in processing speed[4].

Sources

1. Medical News Today: Long-term study proves ADDERALL XR is a safe and effective treatment for adults with ADHD.
2. Drugs.com: Adderall XR User Reviews & Ratings.
3. FDA: Adzenys Clinical Review.
4. ClinicalTrials.Veeva: Adderall XR and Cognitive Impairment in MS.
5. BioSpace: Lannett To Commence Marketing Generic Adderall® XR.

Last updated: 2024-12-31