CLINICAL TRIALS PROFILE FOR ADDERALL 5

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

Clinical Trial Conditions for Adderall 5

Condition Name

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

Clinical Trial Locations for Adderall 5

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Adderall 5

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Adderall 5

Sponsor Name

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

Sponsor Type

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

Understanding ADDERALL: Clinical Trials, Market Analysis, and Projections

Introduction to ADDERALL

ADDERALL, a mixed salts amphetamine product, is a widely used medication for treating Attention Deficit Hyperactivity Disorder (ADHD). It is available in both immediate-release and extended-release formulations, catering to different patient needs based on symptom severity and response to the medication.

Clinical Trials and Efficacy

Long-Term Efficacy of ADDERALL XR

A significant Phase III study presented at the American Psychiatric Association Meeting highlighted the long-term efficacy of ADDERALL XR in adults with ADHD. The 18-month interim analysis of a two-year extension study showed that patients maintained a significant reduction in their ADHD symptoms when treated with ADDERALL XR. This study, led by Harvard investigators, demonstrated that patients did not build up a tolerance to the effects of ADDERALL XR, with many patients experiencing sustained symptom reduction at doses equivalent to those used in the initial four-week study[1].

Symptom Reduction and Dose Optimization

The study revealed a 45% reduction in total symptoms of ADHD in patients who had received placebo during the short-term controlled study and then switched to ADDERALL XR. Specifically, there was a 43% reduction in the ADHD-RS Inattention subscale and a 47% reduction in the ADHD-RS Hyperactive/Impulsive subscale. Dose optimization during the extension study resulted in few patients requiring dose adjustments for the duration of the long-term study[1].

Safety and Tolerability

ADDERALL XR exhibited a good tolerability profile during both trials at all doses. The majority of side effects occurred in the first month of the trial, diminished over time, and were generally mild or moderate in nature. Common drug-related adverse events included dry mouth, loss of appetite, insomnia, and headache[1].

Market Analysis

Global ADHD Market Overview

The global ADHD market, which includes ADDERALL, was estimated at USD 14.3 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.7% from 2024 to 2030, reaching USD 18.6 billion by 2030. The Adderall drug market specifically is expected to grow at a CAGR of 4% from 2023 to 2031, likely reaching a value of USD 28.61 billion by 2031[2].

Regional Market 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].
• Europe: Europe is also 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].

Market Segments

• Stimulant Segment: The stimulant segment, which includes Adderall, accounted for 70.91% of the ADHD market share in 2023 due to its high prescription and usage rates. Stimulants are preferred for their efficacy and immediate results[2].
• Formulations: Adderall is available in both immediate-release and extended-release formulations, catering to different patient needs based on symptom severity and response to the medication[2].

Price Trends and Challenges

Price Increases and Shortages

There has been a significant increase in the prices of ADHD medications, including Adderall, particularly since the Adderall shortage began in October 2022. For example, the price of Adderall XR 10mg increased dramatically from $10 to $158 over a few months. The ongoing shortage, attributed to manufacturing delays and worker shortages, has exacerbated price fluctuations and affected patient access to the medication[2].

Supply and Demand Imbalance

The shortage has led to a supply and demand imbalance, resulting in higher prices. For instance, a supply of 100 capsules of 10mg Adderall XR can cost around $759.54 without insurance coverage. Patients are being advised to consider alternative ADHD medications such as Ritalin, Concerta, and Strattera due to the ongoing shortage of Adderall[2].

Key Players and Market Competition

The Adderall market is highly competitive with several key players, including Novartis AG, Eli Lilly and Company, Johnson & Johnson Services, Inc., Lupin, and Takeda Pharmaceutical Company Limited. These companies are focusing on developing new drugs and therapies to strengthen their market position[2].

Regulatory Environment

ADDERALL is a controlled substance, highly regulated by the U.S. government. The Drug Enforcement Administration (DEA) maintains strict rules on maximum production to avoid patient abuse, which can impact supply and pricing[2].

Future Outlook

Despite current challenges, the Adderall market is expected to continue its growth trajectory. The post-pandemic period is anticipated to see a recovery in supply chain and manufacturing activities, driven by increasing demand for effective ADHD treatments.

Pipeline Agents

Four late-stage pipeline agents targeting core ADHD symptoms are expected to launch in the US market within the forecast period: Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR. These agents are expected to drive moderate market growth but may face hesitancy from key opinion leaders due to perceptions that they do not offer significant added benefits over existing products[3].

Market Growth Drivers and Barriers

The growing awareness of adult ADHD is expected to raise the number of total treated cases, driving market growth. However, barriers such as patent expiries and the launch of generics, particularly lisdexamfetamine dimesylate generics, are expected to overwhelm the drivers, leading to an overall decline in the ADHD market value across some regions[3].

Patient and Healthcare Provider Perspectives

Cost Concerns

The significant price increases have become a major concern for patients and their families. Insurance coverage plays a crucial role in managing these costs, but many families struggle with affordability. 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].

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.
• Price and Supply Challenges: Price increases and shortages are current challenges, but the market is expected to recover and grow in the future.
• Regulatory and Competitive Landscape: Key players are focusing on new drug developments, and regulatory environments and patient affordability remain critical factors.
• Future Projections: Despite current challenges, the market is expected to continue growing, driven by increasing demand for effective ADHD treatments.

FAQs

What is the current market size and growth projection for the Adderall market?

The global ADHD market, including Adderall, was estimated at USD 14.3 billion in 2023 and is projected to grow at a CAGR of 3.7% from 2024 to 2030, reaching USD 18.6 billion by 2030. The Adderall drug market specifically is expected to grow at a CAGR of 4% from 2023 to 2031, likely reaching a value of USD 28.61 billion by 2031[2].

What are the main drivers of the Adderall market growth?

The main drivers include the increasing global prevalence of ADHD, growing awareness among healthcare professionals and patients, and escalating healthcare expenditure[2].

What are the current challenges facing the Adderall market?

Current challenges include significant price increases, ongoing shortages attributed to manufacturing delays and worker shortages, and regulatory constraints[2].

How does the regulatory environment impact the Adderall market?

ADDERALL is a controlled substance, highly regulated by the U.S. government. The DEA maintains strict rules on maximum production to avoid patient abuse, which can impact supply and pricing[2].

What are the future prospects for new ADHD medications?

Four late-stage pipeline agents are expected to launch in the US market, but they may face hesitancy from key opinion leaders due to perceptions that they do not offer significant added benefits over existing products. Despite this, the market is expected to grow driven by increasing demand for effective ADHD treatments[3].

Sources

1. Medical News Today: Long-term study proves ADDERALL XR is a safe and effective treatment for adults with ADHD[1].
2. DrugPatentWatch: Market Analysis and Price Projections for Adderall[2].
3. Clinical Trials Arena: ADHD market forecast to decline by $1bn between 2022 and 2032[3].

Last updated: 2025-01-03