CLINICAL TRIALS PROFILE FOR ADDERALL 30

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

Clinical Trial Conditions for Adderall 30

Condition Name

Condition Name for Adderall 30
Intervention	Trials
Attention Deficit Hyperactivity Disorder	10
Attention Deficit Disorder With Hyperactivity	6
ADHD	3
Cocaine Dependence	3

Condition MeSH

Condition MeSH for Adderall 30
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	22
Hyperkinesis	16
Disease	8
Depressive Disorder	4

Clinical Trial Locations for Adderall 30

Trials by Country

Trials by Country for Adderall 30
Location	Trials
United States	38
Canada	6

Trials by US State

Trials by US State for Adderall 30
Location	Trials
New York	9
Massachusetts	6
Alabama	2
Pennsylvania	2
Minnesota	2

Clinical Trial Progress for Adderall 30

Clinical Trial Phase

Clinical Trial Phase for Adderall 30
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	5

Clinical Trial Status

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

Clinical Trial Sponsors for Adderall 30

Sponsor Name

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

Sponsor Type

Sponsor Type for Adderall 30
Sponsor	Trials
Other	44
Industry	13
NIH	8

Adderall 30: Clinical Trials, Market Analysis, and Projections

Introduction

Adderall, a medication composed of mixed salts of amphetamine, is widely used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both children and adults. This article delves into the clinical trials, market analysis, and future projections for Adderall, particularly focusing on the 30mg formulation.

Clinical Trials Overview

Bioequivalence and Safety Studies

Clinical trials for Adderall, specifically the 30mg formulation, have been conducted to establish bioequivalence and safety. These studies, such as NT0201.1004, NT0201.1005, NT0201.1006, NT0201.1007, and NT0201.1008, involved single-dose and crossover designs to compare the clinical trial formulation with the reference listed drug (RLD), Adderall XR[1].

• Population and Formulation: Studies included children aged 6-12 years with ADHD and healthy adults. The formulations tested were oral suspensions and tablets, both in fasted and fed states.
• Safety Profile: No deaths or non-fatal serious adverse events were reported. Common adverse events included nausea, vomiting, and decreased appetite, which were generally mild or moderate in nature[1].

Long-Term Efficacy and Safety

A Phase III study presented at the American Psychiatric Association Meeting highlighted the long-term efficacy and safety of Adderall XR. This 18-month interim analysis of a two-year trial showed that adults with ADHD experienced significant symptom control with once-daily Adderall XR. The majority of side effects occurred in the first month and diminished over time, with common adverse events including dry mouth, loss of appetite, insomnia, and headache[5].

Market Analysis

Global Market Size and Growth

The global Adderall market is projected to experience significant growth driven by the increasing prevalence of ADHD and growing awareness among healthcare professionals.

• Current Market Size: The global ADHD market, which includes Adderall, was estimated at USD 14.3 billion in 2023[3].
• Growth Projections: The Adderall market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4% from 2023 to 2031, reaching a value of USD 28.61 billion by 2031[2][3].

Regional Dynamics

• North America: This region dominates the Adderall market due to high awareness among healthcare professionals, a rise in disease prevalence, and advanced healthcare infrastructure. The U.S. alone accounted for 69.1% of the global ADHD market revenue in 2023[2][3].
• Europe: Europe is a significant market with key players and increasing investment in research and development activities.
• Asia Pacific: This region is expected to grow at the highest CAGR during the forecast period due to increasing awareness about ADHD and rising healthcare expenditure[2][3].

Patient and Healthcare Provider Perspectives

Cost Concerns

Significant price increases have become a major concern for patients and their families. Insurance coverage and financial assistance programs play crucial roles in managing these costs, but many families still struggle with affordability[2].

Alternative Solutions

Healthcare providers are working with patients to find alternative medications and utilizing manufacturer coupons and other financial assistance programs to make treatments more affordable[2].

Future Outlook

Post-Pandemic Recovery

The COVID-19 pandemic disrupted supply chain and manufacturing activities, but the market is expected to recover in the post-pandemic period. Increasing demand for effective ADHD treatments will drive this recovery[3].

New Drug Developments

Several late-stage pipeline agents, such as Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR, are expected to launch in the US market. These agents will compete with existing treatments, offering differentiations in terms of duration of action and side effect profiles[4].

Key Challenges and Opportunities

Regulatory Environment

Regulatory environments remain critical factors in the Adderall market. Compliance with regulatory requirements and labeling recommendations, such as those discussed during pre-NOA meetings, are essential for market approval and maintenance[1].

Patient Affordability

Ensuring patient affordability is a significant challenge. Key players are focusing on developing new drugs and therapies while also exploring financial assistance programs to make treatments more accessible[2].

Key Takeaways

• Growing Market: The global Adderall market is growing due to increasing ADHD prevalence and awareness.
• Regional Dominance: North America dominates the market, with Europe and the Asia Pacific region also showing significant growth.
• Cost and Affordability: Price increases and shortages are current challenges, but the market is expected to recover and grow in the future.
• New Developments: Key players are focusing on new drug developments and therapies to strengthen their market position.
• Regulatory and Affordability Factors: Regulatory environments and patient affordability remain critical factors.

FAQs

What is the projected growth rate of the Adderall market from 2023 to 2031?

The Adderall market is expected to grow at a CAGR of 4% from 2023 to 2031[2][3].

Which region dominates the Adderall market?

North America dominates the Adderall market, accounting for 69.1% of the global ADHD market revenue in 2023[2][3].

What are the common adverse events associated with Adderall?

Common adverse events include nausea, vomiting, decreased appetite, dry mouth, loss of appetite, insomnia, and headache[1][5].

How has the COVID-19 pandemic affected the Adderall market?

The pandemic disrupted supply chain and manufacturing activities, but the market is expected to recover in the post-pandemic period driven by increasing demand for effective ADHD treatments[3].

What new pipeline agents are expected to impact the Adderall market?

Agents such as Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR are expected to launch in the US market and compete with existing treatments[4].

Sources

1. FDA Clinical Review: Adzenys Clinical Review - FDA[1]
2. DrugPatentWatch: Adderall Market Analysis and Financial Projection[2]
3. Research and Markets: Adderall Drug Market Report and Forecast 2023-2031[3]
4. Clinical Trials Arena: ADHD market forecast to decline by $1bn between 2022 and 2032[4]
5. Medical News Today: Long-term study proves ADDERALL XR is a safe and effective treatment for ADHD[5]