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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR ADDERALL 20


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505(b)(2) Clinical Trials for Adderall 20

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Adderall 20

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Adderall 20

Condition Name

Condition Name for Adderall 20
Intervention Trials
Attention Deficit Hyperactivity Disorder 10
Attention Deficit Disorder With Hyperactivity 6
ADHD 3
Cocaine Dependence 3
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Condition MeSH

Condition MeSH for Adderall 20
Intervention Trials
Attention Deficit Disorder with Hyperactivity 22
Hyperkinesis 16
Disease 8
Depressive Disorder 4
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Clinical Trial Locations for Adderall 20

Trials by Country

Trials by Country for Adderall 20
Location Trials
United States 38
Canada 6
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Trials by US State

Trials by US State for Adderall 20
Location Trials
New York 9
Massachusetts 6
Illinois 2
Maryland 2
Georgia 2
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Clinical Trial Progress for Adderall 20

Clinical Trial Phase

Clinical Trial Phase for Adderall 20
Clinical Trial Phase Trials
Phase 4 13
Phase 3 3
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Adderall 20
Clinical Trial Phase Trials
Completed 21
Recruiting 7
Terminated 4
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Clinical Trial Sponsors for Adderall 20

Sponsor Name

Sponsor Name for Adderall 20
Sponsor Trials
Shire 7
National Institute on Drug Abuse (NIDA) 5
New York State Psychiatric Institute 5
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Sponsor Type

Sponsor Type for Adderall 20
Sponsor Trials
Other 44
Industry 13
NIH 8
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Adderall 20: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy of Adderall

Long-Term Efficacy in Adult ADHD

A significant two-year study presented at the U.S. Psychiatric & Mental Health Congress demonstrated the long-term efficacy of Adderall XR in controlling ADHD symptoms in adults. The study, led by Harvard Medical School investigators, involved 255 adult patients and showed that Adderall XR maintained a significant reduction in ADHD symptoms over 24 months. Patients who started Adderall XR for the first time during the open-label extension showed the most improvement, with a mean reduction in ADHD-RS total scores of -11.6 (P < .001)[1].

Tolerability and Side Effects

The study also highlighted that Adderall XR exhibited a good tolerability profile, with the majority of side effects being mild or moderate and diminishing over time. Common side effects included dry mouth, insomnia, loss of appetite, headache, and nervousness[1].

Ongoing Research and Development

In the broader ADHD treatment landscape, clinical trials are predominantly in the late phases of development, with 54% of trials in Phase III-IV and 46% in Phase I-II. The US leads in the number of ADHD clinical trials globally, followed by Germany in Europe and Japan in Asia. Companies like Takeda have a significant presence, with 159 completed clinical trials for ADHD[3].

Market Analysis

Market Size and Growth Projections

The global Adderall market is expected to experience substantial growth driven by the rising prevalence of ADHD. As of 2023, the market size was approximately USD 20.90 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4% from 2025 to 2034, reaching a value of about USD 29.75 billion by 2032[2][5].

Regional Market Dynamics

North America dominates the Adderall market due to high awareness among healthcare professionals, increased disease prevalence, and advanced healthcare infrastructure. The U.S. alone accounted for 69.1% of the global ADHD market revenue in 2023. Europe and the Asia Pacific are also significant markets, with the latter expected to grow at the highest CAGR during the forecast period due to increasing awareness and rising healthcare expenditure[5].

Segmentations and Preferences

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. 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[5].

Market Challenges and Trends

Price Increases and Shortages

The Adderall market has been impacted by significant price increases, particularly since the shortage began in October 2022. Prices for certain dosages have nearly doubled or tripled, affecting patient access to the medication. For instance, 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 led to a supply and demand imbalance, resulting in higher prices[5].

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. This regulatory environment adds another layer of complexity to the market dynamics[5].

Patient and Healthcare Provider Perspectives

Cost Concerns and Alternative Solutions

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 such as Ritalin, Concerta, and Strattera, and utilizing manufacturer coupons and other financial assistance programs to make treatments more affordable[5].

Future Outlook

Recovery in Supply Chain and Manufacturing

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. Telehealth prescriptions of controlled substances like Adderall, permitted by the US Drug Enforcement Agency during the pandemic, have also contributed to market growth[2].

Increasing Prevalence and Awareness

The rising global prevalence of ADHD, particularly among adults and the senior population, is a major driver of market growth. Increased awareness among healthcare professionals and patients, along with escalating healthcare expenditure, are also contributing factors[2][5].

"The rising demand of Adderall drug market can be attributed to telehealth prescriptions of controlled substances like Adderall and Ritalin by online mental health care startups that were established during the pandemic and were permitted to do so by the US Drug Enforcement Agency."[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[5].

Conclusion

Adderall, particularly the 20mg dose, remains a crucial treatment option for ADHD, backed by robust clinical evidence of its efficacy and tolerability. Despite current market challenges such as price increases and shortages, the market is poised for continued growth driven by increasing prevalence, awareness, and healthcare expenditure.

Key Takeaways

  • Efficacy and Tolerability: Adderall XR has demonstrated long-term efficacy in controlling ADHD symptoms in adults with a good tolerability profile.
  • Market Growth: The global Adderall market is expected to grow at a CAGR of 4% from 2025 to 2034, driven by the rising prevalence of ADHD.
  • Regional Dynamics: North America dominates the market, with the Asia Pacific region expected to grow at the highest CAGR.
  • Challenges: The market faces challenges such as price increases and shortages, impacting patient access.
  • Future Outlook: The market is expected to recover in the post-pandemic period with increased demand and improved supply chain and manufacturing activities.

FAQs

What is the primary driver of the Adderall market growth?

The primary driver of the Adderall market growth is the rising prevalence rate of ADHD, along with increasing awareness among healthcare professionals and patients, and escalating healthcare expenditure[2][5].

What are the common side effects of Adderall?

Common side effects of Adderall include dry mouth, insomnia, loss of appetite, headache, and nervousness. In children and adolescents, side effects may also include decreased appetite, difficulty falling asleep, stomachache, and emotional lability[1][4].

How does the regulatory environment impact the Adderall market?

The Adderall market is highly regulated by the U.S. government, with the DEA maintaining strict rules on maximum production to avoid patient abuse. This regulatory environment can impact supply and pricing[5].

What are the alternative medications for ADHD due to the Adderall shortage?

Patients are being advised to consider alternative ADHD medications such as Ritalin, Concerta, and Strattera due to the ongoing shortage of Adderall[5].

How does the extended-release formulation of Adderall work?

Adderall XR uses a double-bead formulation where half of the beads provide immediate administration of medication, and the other half are enveloped in a coating that delays absorption, providing a therapeutic effect for up to 12 hours[4].

Sources

  1. Shire Pharmaceuticals Group plc Announces Positive Results Of Two-Year Study Of ADDERALL XR(R) In The Treatment Of Adult ADHD. Biospace, 2005.
  2. Adderall Drug Market Size, Share | Industry Statistics 2034. Expert Market Research.
  3. Attention Deficit Hyperactivity Disorder (ADHD) Market Spotlight Report 2021. Businesswire.
  4. Adderall. Wikipedia.
  5. Drug prices and trends for adderall. DrugPatentWatch.

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