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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR ADDERALL 15


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

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

All Clinical Trials for Adderall 15

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for Adderall 15

Condition Name

106330-101234567891011Attention Deficit Hyperactivity DisorderAttention Deficit Disorder With HyperactivityMajor Depressive DisorderADHD[disabled in preview]
Condition Name for Adderall 15
Intervention Trials
Attention Deficit Hyperactivity Disorder 10
Attention Deficit Disorder With Hyperactivity 6
Major Depressive Disorder 3
ADHD 3
[disabled in preview] 0
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Condition MeSH

2216840-2024681012141618202224Attention Deficit Disorder with HyperactivityHyperkinesisDiseaseDepressive Disorder[disabled in preview]
Condition MeSH for Adderall 15
Intervention Trials
Attention Deficit Disorder with Hyperactivity 22
Hyperkinesis 16
Disease 8
Depressive Disorder 4
[disabled in preview] 0
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Clinical Trial Locations for Adderall 15

Trials by Country

+
Trials by Country for Adderall 15
Location Trials
United States 38
Canada 6
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Trials by US State

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

Clinical Trial Phase

41.9%9.7%16.1%32.3%0234567891011121314Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Adderall 15
Clinical Trial Phase Trials
Phase 4 13
Phase 3 3
Phase 2/Phase 3 5
[disabled in preview] 10
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Clinical Trial Status

53.8%17.9%10.3%17.9%046810121416182022CompletedRecruitingTerminated[disabled in preview]
Clinical Trial Status for Adderall 15
Clinical Trial Phase Trials
Completed 21
Recruiting 7
Terminated 4
[disabled in preview] 7
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Clinical Trial Sponsors for Adderall 15

Sponsor Name

trials01234567ShireNew York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)[disabled in preview]
Sponsor Name for Adderall 15
Sponsor Trials
Shire 7
New York State Psychiatric Institute 5
National Institute on Drug Abuse (NIDA) 5
[disabled in preview] 7
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Sponsor Type

66.7%19.7%12.1%0051015202530354045OtherIndustryNIH[disabled in preview]
Sponsor Type for Adderall 15
Sponsor Trials
Other 44
Industry 13
NIH 8
[disabled in preview] 1
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Understanding Adderall: 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). This article delves into the clinical trials, market analysis, and future projections for Adderall, particularly focusing on the 15 mg dosage.

Clinical Trials and Safety Profile

Bioequivalence and Safety Studies

Clinical trials for Adderall, particularly those involving its extended-release formulation (Adderall XR), have been extensive. The FDA has reviewed several bioequivalence and food effect studies to ensure the safety and efficacy of these formulations. For instance, studies like NT0201.1005, NT0201.1006, NT0201.1007, and NT0201.1008 were conducted to compare the safety of clinical trial and commercial formulations of Adderall XR against the reference listed drug (RLD)[1].

These studies revealed no new, unlabeled safety signals, and the most commonly reported adverse events were nausea, vomiting, and decreased appetite, affecting around 5-7% of the participants. There were no deaths or non-fatal serious adverse events reported in these studies[1].

Comparative Studies

A pilot study comparing immediate-release Adderall (IR) and extended-release Adderall XR (XR) in adults with ADHD highlighted the effectiveness and side effects of both formulations. This randomized, cross-over study involved participants taking either Adderall IR or Adderall XR for three weeks, with a washout period in between. The study focused on dosing adherence, treatment efficacy, and medical evaluations including weight, blood pressure, and pulse[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 by 2032. This decline is largely due to patent expiries and the increasing availability of generic versions of ADHD medications, such as lisdexamfetamine dimesylate generics[3].

Impact of Generic and Pipeline Products

The launch of generic versions of ADHD medications is a significant market driver. Generic products are often more attractive due to their lower cost, which can limit the uptake of novel, more expensive pipeline products. Despite the forecasted launch of four new pipeline agents in the US market by 2026, these products are not expected to show significant improvements in efficacy but rather in duration of action and reduction of side effects[3].

Street Market and Misuse

Adderall is also sold on the black market, with prices varying widely depending on factors such as dosage, quantity, local availability, and formulation. The street price for a 15 mg pill can range from $2 to $10. This illicit market highlights the potential for misuse and the need for stringent regulation and public health measures[2][5].

Market Projections

Growing Awareness of Adult ADHD

Despite the overall decline in the ADHD market value, there is an expected increase in the number of treated cases due to growing awareness of adult ADHD. This increase could slightly offset the decline caused by patent expiries and the rise of generics[3].

Pipeline Agents

The upcoming launch of pipeline agents like Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR may drive moderate market growth. However, these products are expected to compete against existing non-stimulant medications rather than offering significant efficacy improvements[3].

Key Takeaways

  • Clinical Trials: Adderall XR has demonstrated bioequivalence to the RLD with no new safety findings. Studies have shown common adverse events like nausea and decreased appetite.
  • Market Trends: The ADHD market is expected to decline due to patent expiries and the rise of generics.
  • Pipeline Products: New pipeline agents will focus on duration of action and side effect reduction rather than efficacy improvements.
  • Street Market: Adderall is sold illicitly, with prices varying based on several factors, highlighting the need for regulation.
  • Growing Awareness: Increasing awareness of adult ADHD may lead to more treated cases, slightly offsetting market decline.

FAQs

What are the common adverse events associated with Adderall?

The most commonly reported adverse events associated with Adderall include nausea, vomiting, and decreased appetite[1].

How does the street price of Adderall vary?

The street price of Adderall varies based on factors such as dosage, quantity, local availability, and formulation, with a 15 mg pill ranging from $2 to $10[2][5].

What is the forecast for the ADHD market?

The ADHD market is expected to decline at a negative CAGR of 0.9% from $11.9 billion in 2022 to $10.9 billion by 2032[3].

What new pipeline agents are expected to launch in the ADHD market?

Pipeline agents such as CTx-1301, solriamfetol hydrochloride, centanafadine SR, and NRCT-101SR are expected to launch in the US market by 2026[3].

Why is the ADHD market declining despite growing awareness of adult ADHD?

The decline is primarily due to patent expiries and the increasing availability of generic ADHD medications, which are more cost-effective than new pipeline products[3].

Sources

  1. FDA Clinical Review: Adzenys Clinical Review - FDA
  2. NCADD.org: How Much Does Adderall Cost?
  3. Clinical Trials Arena: 7MM ADHD market forecast to decline by $1bn between 2022 and 2032
  4. Veeva Clinical Trials: A Within-Subject Cross-Over Comparison Between Immediate-Release and Extended-Release Adderall
  5. Bedrock Recovery Center: Average Street Price Of Adderall

More… ↓

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