CLINICAL TRIALS PROFILE FOR ADDERALL XR 15

505(b)(2) Clinical Trials for Adderall Xr 15

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 15

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.

Clinical Trial Conditions for Adderall Xr 15

Condition Name

Condition Name for Adderall Xr 15
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 15
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	22
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for Adderall Xr 15

Trials by Country

Trials by Country for Adderall Xr 15
Location	Trials
United States	38
Canada	6

Trials by US State

Trials by US State for Adderall Xr 15
Location	Trials
New York	9
Massachusetts	6
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for Adderall Xr 15

Clinical Trial Phase

Clinical Trial Phase for Adderall Xr 15
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Adderall Xr 15
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for Adderall Xr 15

Sponsor Name

Sponsor Name for Adderall Xr 15
Sponsor	Trials
Shire	7
New York State Psychiatric Institute	5
National Institute on Drug Abuse (NIDA)	5

Sponsor Type

Sponsor Type for Adderall Xr 15
Sponsor	Trials
Other	44
Industry	13
NIH	8

Adderall XR: Clinical Trials, Market Analysis, and Projections

Introduction

Adderall XR, an extended-release formulation of a mixed salt of a single entity amphetamine, is a central nervous system (CNS) stimulant widely used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Here, we will delve into recent clinical trials, market analysis, and projections for this medication.

Clinical Trials Overview

Comparative Studies

A significant clinical trial compared the effectiveness and side effects of Adderall (immediate release) and Adderall XR (extended release) in adults with ADHD. This randomized, cross-over study involved participants receiving three weeks of treatment with each formulation, with a washout period in between. The study aimed to evaluate dosing adherence, treatment efficacy, and side effects. Participants visited the clinic weekly for evaluations, and medical assessments included weight, blood pressure, and pulse checks[1].

Bioequivalence Studies

Several bioequivalence studies have been conducted to compare generic versions of Adderall XR with the brand-name product. For instance, a study by the FDA compared the commercial scale formulation of Amphetamine ER oral suspension with Adderall XR. The results showed similar pharmacokinetic profiles and bioequivalence for d- and l-amphetamine exposures, indicating that the generic formulation is as effective and safe as the brand-name product[3][4].

Market Analysis

Market Value and Competition

The market for Adderall XR, including its generic versions, is substantial, with an estimated IQVIA market value of approximately $1.3 billion for the 12 months ending January 2020. This market is highly competitive, with multiple generic suppliers, including Lannett Company, Elite Pharmaceuticals, and SunGen Pharma LLC. These companies have launched generic versions of Adderall XR in various strengths, ranging from 5 mg to 30 mg capsules[2][5].

Generic Launches

Lannett Company, in partnership with Elite Pharmaceuticals and SunGen Pharma LLC, has commenced marketing a generic version of Adderall XR. This launch is part of Lannett's strategy to expand its portfolio of generic pharmaceutical products, aiming to provide more affordable treatment options for patients with ADHD[2][5].

Market Projections

Growth and Demand

The demand for ADHD medications, including Adderall XR, is expected to continue growing due to increasing diagnoses and the need for effective treatment options. The extended-release formulation of Adderall XR offers a convenient once-daily dosing regimen, which is likely to maintain its market share despite the presence of generic competitors.

Competitive Landscape

The entry of multiple generic versions is expected to increase competition, potentially driving down prices and making the medication more accessible to a broader patient population. However, brand loyalty and the reputation of the original manufacturer may still influence market dynamics.

Regulatory Environment

The FDA's approval of generic versions of Adderall XR ensures that these products meet stringent safety and efficacy standards. This regulatory oversight is crucial for maintaining consumer trust and ensuring the quality of generic medications in the market[3][4].

Safety and Efficacy

Adverse Events

Clinical trials have shown that Adderall XR and its generic versions have a similar safety profile. Common adverse events include nausea, decreased appetite, and other mild side effects. No new safety signals or serious adverse events have been identified in the studies conducted to support the approval of generic versions[3][4].

Efficacy

The efficacy of Adderall XR and its generic counterparts has been well-established through bioequivalence studies. These studies demonstrate that the generic formulations provide similar exposures of d- and l-amphetamine, ensuring that patients receive the same therapeutic benefits as the brand-name product[3][4].

Key Takeaways

• Clinical Trials: Recent studies have compared the effectiveness and side effects of Adderall XR with its immediate-release counterpart and established bioequivalence with generic versions.
• Market Analysis: The market for Adderall XR is valued at approximately $1.3 billion, with multiple generic suppliers entering the market.
• Market Projections: The demand for ADHD medications is expected to grow, with generic versions likely to increase accessibility and drive competition.
• Safety and Efficacy: Clinical trials have confirmed the safety and efficacy of Adderall XR and its generic versions, aligning with FDA standards.

FAQs

What is Adderall XR used for?

Adderall XR is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. It is a central nervous system (CNS) stimulant.

How does Adderall XR differ from Adderall?

Adderall XR is an extended-release formulation, providing a once-daily dosing regimen, whereas Adderall is an immediate-release formulation that requires multiple daily doses.

Are generic versions of Adderall XR available?

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

What are the common side effects of Adderall XR?

Common side effects include nausea, decreased appetite, and other mild adverse events.

How do generic versions of Adderall XR compare to the brand-name product?

Generic versions of Adderall XR have been shown to be bioequivalent to the brand-name product, ensuring similar efficacy and safety profiles.

Sources

1. CTV.Veeva.com: A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall.
2. BioSpace: Lannett Begins Marketing Generic Adderall® XR.
3. FDA: Office of Clinical Pharmacology Review - FDA.
4. FDA: Adzenys Clinical Review - FDA.
5. Elite Pharmaceuticals: Elite Pharmaceuticals Announces Commercial Launch of Generic Adderall XR.

Last updated: 2025-01-01