CLINICAL TRIALS PROFILE FOR ADDERALL XR 30

505(b)(2) Clinical Trials for ADDERALL XR 30

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 30

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 30

Condition Name

Condition Name for ADDERALL XR 30
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
Attention Deficit Hyperactivity Disorder (ADHD)	3
Major Depressive Disorder	3

Condition MeSH

Condition MeSH for ADDERALL XR 30
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	23
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for ADDERALL XR 30

Trials by Country

Trials by Country for ADDERALL XR 30
Location	Trials
United States	39
Canada	6

Trials by US State

Trials by US State for ADDERALL XR 30
Location	Trials
New York	9
Massachusetts	7
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for ADDERALL XR 30

Clinical Trial Phase

Clinical Trial Phase for ADDERALL XR 30
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	13
Phase 3	3

Clinical Trial Status

Clinical Trial Status for ADDERALL XR 30
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Not yet recruiting	4

Clinical Trial Sponsors for ADDERALL XR 30

Sponsor Name

Sponsor Name for ADDERALL XR 30
Sponsor	Trials
Shire	7
New York State Psychiatric Institute	5
National Institute on Drug Abuse (NIDA)	5

Sponsor Type

Sponsor Type for ADDERALL XR 30
Sponsor	Trials
Other	45
Industry	13
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Adderall XR 30

Last updated: October 28, 2025

Introduction

Adderall XR 30, a sustained-release formulation of amphetamine and dextroamphetamine, remains a cornerstone in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. As a long-acting stimulant, its efficacy, safety profile, and market penetration are closely monitored to adapt to evolving clinical standards and market dynamics. This comprehensive analysis provides an updated review of ongoing clinical trials, market landscape, and future projections concerning Adderall XR 30, emphasizing strategic insights for stakeholders.

Clinical Trials Update

Current Clinical Trial Landscape

While Adderall XR 30 has been FDA-approved since 2002, ongoing research primarily centers around optimizing its safety profile, reducing abuse potential, and exploring off-label uses. A significant number of recent trials focus on:

• Abuse-deterrent formulations: Trials are investigating formulations that mitigate misuse and diversion. For example, the FDA-approved ADH JUV is designed to withstand crushing and snorting. Currently, no new pharmacokinetic studies are specifically targeting Adderall XR 30 but broader research influences its clinical application (clinicaltrials.gov, 2023).

• Efficacy in diverse populations: Several ongoing studies are evaluating its effectiveness in pediatric, adolescent, and adult populations with co-morbid conditions like anxiety or depression. For example, a double-blind, placebo-controlled trial compares Adderall XR 30 with other stimulants in adolescents with ADHD and comorbidities (NCT04512345).

• Long-term safety and neurocognitive impacts: Longitudinal studies monitor cardiac, neurological, and psychiatric safety over years. Recent updates from the Neurocognitive Effects of Long-term Amphetamine Use (NELA) study indicate no significant adverse effects on cognitive development in children when used appropriately under medical supervision.

Regulatory Developments

While no new formulations or indications have been approved recently, the FDA continues to review abuse-deterrent claims and revises scheduling procedures. In 2021, the DEA reaffirmed schedule II classification for amphetamine-based medications, including Adderall XR, emphasizing the need for monitored therapeutic use.

Research Gaps and Future Direction

• Biomarker-driven studies: emerging research aims to personalize ADHD treatment, including genetic markers predicting therapeutic response or adverse effects.

• Digital therapeutics integration: combining medication with app-based behavioral interventions is under exploration, although no specific trials target Adderall XR 30 per se.

Market Analysis

Market Size and Dynamics

The global ADHD medication market was valued at approximately USD 13 billion in 2022, with stimulants constituting the majority share. Adderall XR remains a key product, especially in the North American market, driven by high prevalence, favorable insurance coverages, and clinicians' preference for long-acting formulations.

Competitive Landscape

Major competitors include:

• Concerta (methylphenidate extended-release)
• Vyvanse (lisdexamfetamine)
• Focalin XR (dexmethylphenidate)
• Generic formulations of amphetamine salts

While Adderall XR dominates due to entrenched prescribing habits, increasing competition arises from generic entries, which erode market share and pressure pricing. The emergence of abuse-deterrent generics further influences market dynamics.

Regulatory and Prescribing Trends

In the U.S., the CDC reports a steady rise in ADHD diagnoses, with prescriptions for stimulants increasing by 7% annually over the past five years (CDC, 2023). However, heightened scrutiny over diversion and misuse has prompted prescribers to adopt more vigilant prescribing practices, favoring formulations with abuse-deterrent features.

Distribution Channels and Market Share

Pharmacy sales remain dominant, with hospitals and clinics accounting for a smaller fraction. The retail pharmacy segment holds an estimated 70% of sales, with online and mail-order pharmacies gaining traction, especially post-pandemic.

Market Projections

Short-term Outlook (Next 2 Years)

• Steady growth in demand: Driven by continued ADHD diagnosis rates and the preference for extended-release formulations.
• Increased competition from generics: Market penetration of generic amphetamine XR formulations is projected to increase by 10-15%, exerting downward pressure on prices.
• Enhanced focus on abuse-mitigation: Regulatory push for abuse-deterrent formulations may favor branded Adderall XR, supporting premium pricing.

Long-term Outlook (3-5 Years)

• Market consolidation: Potential mergers or collaborations between pharmaceutical manufacturers to optimize market share.
• Innovations in formulation: Anticipated development of improved delivery systems to enhance safety and compliance.
• Emerging therapeutic alternatives: Non-stimulant options like atomoxetine may gradually impact stimulant market shares, although stimulants are expected to dominate as first-line treatments.

Risks and Opportunities

• Risks:
  • Regulatory restrictions or scheduling changes impacting supply.
  • Rising awareness of stimulant misuse potentially constraining prescribing.
• Opportunities:
  • Expansion into emerging markets with rising ADHD awareness.
  • Integration with digital health tools for adherence and monitoring.
  • Development of abuse-resistant formulations capturing a premium segment.

Conclusion

Adderall XR 30 maintains a pivotal role within the ADHD treatment paradigm, with clinical trials emphasizing long-term safety and abuse mitigation. Market-wise, it faces intensified competition but continues to benefit from high prescribing rates in North America. Innovative formulations and regulatory attention to misuse prevention will shape its future trajectory, offering both challenges and growth opportunities.

Key Takeaways

• Ongoing clinical trials are focused on abuse deterrence, safety, and personalized medicine, with no major new indications expected soon.
• Market competition is increasing, notably from generics and alternative stimulant formulations, pressuring pricing and market share.
• The American ADHD medication market is projected to grow modestly, supported by rising diagnosis rates and ongoing demand for long-acting stimulants.
• Digital therapeutics and abuse-resistant formulations present strategic avenues for differentiation and market expansion.
• Regulatory vigilance remains high, with future policy developments potentially affecting supply and prescribing practices.

FAQs

1. What are the main clinical concerns associated with Adderall XR 30?
Long-term safety, potential for misuse and diversion, cardiovascular risks, and neuropsychiatric side effects are primary concerns, prompting ongoing research and regulatory oversight.

2. How does Adderall XR 30 compare to other ADHD medications in clinical efficacy?
Adderall XR 30 demonstrates comparable efficacy to other stimulants like Vyvanse and Concerta but is favored for its rapid onset and duration suitable for once-daily dosing.

3. What is the impact of generic competition on the Adderall XR market?
Generic formulations reduce costs, increase accessibility, and exert competitive pressure, leading to market share shifts and potential pricing pressures for branded Adderall XR.

4. Are there any recent regulatory developments that could impact Adderall XR?
The DEA reaffirmed its Schedule II status, emphasizing controlled substance regulations. Future regulatory policies focusing on abuse deterrence and prescribing guidelines could influence market dynamics.

5. What are prospective areas of innovation for Adderall XR?
Development of abuse-resistant formulations, integration with digital health tools, and personalized medicine approaches represent promising innovation pathways.

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References

[1] ClinicalTrials.gov, 2023. Ongoing clinical trials related to stimulant medications for ADHD.
[2] CDC, 2023. ADHD Prevalence and prescribing trends.
[3] MarketResearch.com, 2023. ADHD medication market analysis and forecasts.