CLINICAL TRIALS PROFILE FOR ADDERALL 12.5

505(b)(2) Clinical Trials for Adderall 12.5

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 12.5

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 12.5

Condition Name

Condition Name for Adderall 12.5
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 12.5
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	22
Hyperkinesis	16
Disease	8
Depression	4

Clinical Trial Locations for Adderall 12.5

Trials by Country

Trials by Country for Adderall 12.5
Location	Trials
United States	38
Canada	6

Trials by US State

Trials by US State for Adderall 12.5
Location	Trials
New York	9
Massachusetts	6
Georgia	2
Florida	2
Alabama	2

Clinical Trial Progress for Adderall 12.5

Clinical Trial Phase

Clinical Trial Phase for Adderall 12.5
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for Adderall 12.5
Clinical Trial Phase	Trials
Completed	21
Recruiting	7
Terminated	4

Clinical Trial Sponsors for Adderall 12.5

Sponsor Name

Sponsor Name for Adderall 12.5
Sponsor	Trials
Shire	7
National Institute on Drug Abuse (NIDA)	5
New York State Psychiatric Institute	5

Sponsor Type

Sponsor Type for Adderall 12.5
Sponsor	Trials
Other	44
Industry	13
NIH	8

Adderall 12.5 mg: Clinical Trials, Market Analysis, and Projections

Introduction

Adderall, a combination of amphetamine and dextroamphetamine, is a widely used prescription medication for treating attention-deficit/hyperactivity disorder (ADHD). Here, we will delve into the clinical trials, market analysis, and projections for Adderall, particularly focusing on the 12.5 mg dosage.

Clinical Trials and Efficacy

Efficacy in Adults

A significant clinical trial published in the Archives of General Psychiatry in 2001 demonstrated the efficacy of Adderall in adults with ADHD. The study involved a double-blind, placebo-controlled, crossover design where participants were randomized to receive either Adderall or a placebo. The results showed that Adderall significantly improved ADHD symptoms, with a 42% decrease on the ADHD Rating Scale, and was well tolerated at an average oral dose of 54 mg per day, administered in two daily doses[1].

Comparison with Ritalin

A study conducted by William R. Pelham, Ph.D., at the University at Buffalo compared the efficacy of Adderall with Ritalin in children with ADHD. This trial found that Adderall was at least as effective as Ritalin in improving behavior and academic performance, and it had a longer-lasting effect, particularly four to five hours after ingestion when Ritalin's effects had worn off. Adderall was preferred by staff as the medication of choice for 52% of the children, highlighting its effectiveness and longer duration of action[4].

Market Analysis

Current Market Trends

The ADHD market, which includes Adderall, is expected to decline at a negative Compound Annual Growth Rate (CAGR) of 0.9% from $11.9 billion in 2022 to $10.9 billion in 2032 across seven major markets (7MM). This decline is partly due to the patent expirations of key products and the introduction of generic alternatives[3].

Pipeline Agents

Several new pipeline agents are expected to launch in the US market by 2026, including Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR. These agents are anticipated to drive moderate market growth but are not expected to significantly improve efficacy over current products. Instead, they will offer differentiation in terms of increased duration of action and reduced side effects[3].

Market Projections

Impact of New Agents

The introduction of new agents, while expected to capture some market share, is not anticipated to significantly alter the overall market size. Key opinion leaders (KOLs) have expressed skepticism about the added benefits of these new products, which could limit their adoption. Additionally, the premium pricing of these innovator agents upon market entry may also be a deterrent once initial promotion incentives are withdrawn[3].

Generic and Extended-Release Forms

The availability of generic and extended-release forms of Adderall is likely to continue influencing market dynamics. Generic versions often reduce the cost burden for patients, making the medication more accessible. Extended-release forms, such as Adderall XR, offer the convenience of once-daily dosing, which can improve compliance and reduce the stigma associated with multiple daily doses[4].

Street Value and Misuse

Street Prices

Adderall, including the 12.5 mg dosage, is often sold on the black market, with prices varying widely depending on factors such as dosage, quantity purchased, local availability, and formulation. Street prices can range from $2.50 to $35 per pill, with the 12.5 mg dosage typically costing between $3 to $10 per pill[2][5].

Misuse and Addiction

The misuse of Adderall for its stimulant effects is a significant concern. When abused, Adderall can cause euphoria, increased energy, and enhanced focus, but it also carries the risk of addiction and negative health consequences. Treatment options for Adderall abuse include detoxification, inpatient or residential rehab, and various behavioral therapies[5].

Key Takeaways

• Efficacy: Adderall 12.5 mg has been shown to be effective in treating ADHD in both adults and children, with a longer duration of action compared to Ritalin.
• Market Trends: The ADHD market is expected to decline slightly due to patent expirations and the introduction of generics.
• Pipeline Agents: New agents are expected to launch but may not offer significant improvements in efficacy.
• Street Value: Adderall is sold on the black market with varying prices, and its misuse is a significant health concern.
• Treatment: Various treatment options are available for those who abuse or are addicted to Adderall.

FAQs

What is the typical dosage of Adderall for ADHD?

The typical dosage of Adderall for ADHD can vary but often ranges from 5 mg to 30 mg per day, administered in divided doses. For example, a common dosage is 12.5 mg twice daily[1][4].

How does Adderall compare to Ritalin in treating ADHD?

Adderall has been shown to be at least as effective as Ritalin in improving behavior and academic performance in children with ADHD, with a longer duration of action[4].

What are the potential side effects of Adderall?

Common side effects of Adderall include insomnia, dry mouth, loss of appetite, and anxiety. At higher doses or with prolonged use, more serious side effects can occur[1].

Why is Adderall often misused?

Adderall is misused for its stimulant effects, which can include increased energy, enhanced focus, and euphoria. However, this misuse can lead to addiction and other negative health consequences[5].

What treatment options are available for Adderall addiction?

Treatment options for Adderall addiction include detoxification, inpatient or residential rehab, substance abuse counseling, individual and group therapy, and medical and psychiatric care[5].

Sources

1. Spencer T, Biederman J, Wilens T, et al. Efficacy of a Mixed Amphetamine Salts Compound in Adults With Attention-Deficit/Hyperactivity Disorder. Arch Gen Psychiatry. 2001;58(8):775–782. doi:10.1001/archpsyc.58.8.775
2. NCADD.org How Much Does Adderall Cost? - NCADD.org
3. Clinical Trials Arena 7MM ADHD market forecast to decline by $1bn between 2022 and 2032.
4. University at Buffalo First Trial Comparing Adderall to Ritalin For ADHD Shows It to Be Longer-Lasting, Equally As Effective
5. Bedrock Recovery Center Average Street Price Of Adderall - Bedrock Recovery Center

Last updated: 2024-12-31