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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR FOCALIN


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All Clinical Trials for Focalin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00361387 ↗ Use of Focalin for Fatigue in Sarcoidosis Completed University of Cincinnati Phase 4 2006-06-01 Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis and its treatment can greatly affect your quality of life. Many patients suffer from fatigue (feeling tired), lack of focus and concentration, in ability to organize their daily activities, and memory loss. These commonly reported symptoms often get in the way of everyday life.
NCT00393042 ↗ Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR Completed Novartis Phase 3 2006-01-01 The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
NCT00393042 ↗ Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR Completed Seattle Children's Hospital Phase 3 2006-01-01 The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
NCT00393042 ↗ Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR Completed University of Illinois at Chicago Phase 3 2006-01-01 The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
NCT00429273 ↗ Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder Completed National Institute of Mental Health (NIMH) Phase 4 2007-01-01 This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
NCT00429273 ↗ Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder Completed University of California, Los Angeles Phase 4 2007-01-01 This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
NCT00564954 ↗ A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) Completed Novartis Pharmaceuticals Phase 4 2007-10-01 This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Focalin

Condition Name

Condition Name for Focalin
Intervention Trials
Attention Deficit Hyperactivity Disorder 4
Healthy 3
Problem Behavior 1
Sarcoidosis 1
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Condition MeSH

Condition MeSH for Focalin
Intervention Trials
Attention Deficit Disorder with Hyperactivity 6
Hyperkinesis 4
Disease 2
Sarcoidosis 1
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Clinical Trial Locations for Focalin

Trials by Country

Trials by Country for Focalin
Location Trials
United States 14
Switzerland 1
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Trials by US State

Trials by US State for Focalin
Location Trials
Massachusetts 3
Missouri 2
Nevada 1
Florida 1
Arkansas 1
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Clinical Trial Progress for Focalin

Clinical Trial Phase

Clinical Trial Phase for Focalin
Clinical Trial Phase Trials
Phase 4 5
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Focalin
Clinical Trial Phase Trials
Completed 11
Recruiting 1
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Clinical Trial Sponsors for Focalin

Sponsor Name

Sponsor Name for Focalin
Sponsor Trials
Massachusetts General Hospital 3
Teva Pharmaceuticals USA 2
University Hospital, Basel, Switzerland 1
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Sponsor Type

Sponsor Type for Focalin
Sponsor Trials
Other 10
Industry 5
NIH 1
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Focalin: Clinical Trials, Market Analysis, and Projections

Introduction

Focalin, a medication containing dexmethylphenidate, is widely used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in both children and adults. This article delves into the clinical trials that have established its efficacy, the current market analysis, and future projections for this drug.

Clinical Trials Overview

Pediatric Patients

Clinical trials have demonstrated the efficacy and safety of Focalin XR in pediatric patients. A randomized, double-blind, placebo-controlled study involving 103 pediatric patients aged 6 to 17 showed significant improvements in ADHD symptoms. Patients received a flexible dose of Focalin XR (5 to 30mg/day) or placebo once daily for 7 weeks. The primary efficacy outcome measure was the mean change from baseline to endpoint using the Conners ADHD/DSM-IV Scales for teachers (CADS-T). Results indicated a statistically significant treatment effect for Focalin XR compared to placebo, with a placebo-subtracted difference of 10.64 (95% CI, 5.38-15.91)[1].

Adult Patients

Similar efficacy was observed in adult patients. A study involving 221 adults aged 18 to 60 who met DSM-IV criteria for ADHD showed that all three doses of Focalin XR (20, 30, and 40mg/day) achieved statistically significant treatment effects compared to placebo. The primary efficacy outcome measure was the mean change from baseline to endpoint using the investigator-administered DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS)[1].

Pharmacokinetics and Special Populations

The pharmacokinetics of dexmethylphenidate, the active ingredient in Focalin, have been studied in various populations. The mean plasma elimination half-life of dexmethylphenidate is approximately 2.2 hours. Studies have shown similar pharmacokinetic parameters for boys and girls, and while there are some differences in adult female and male volunteers, these are not clinically significant[3].

Market Analysis

Current Market Size

The global ADHD market, which includes medications like Focalin, was valued at USD 9.6 billion in 2023. This market is driven by increasing diagnoses of ADHD and advancements in treatment services, including research into genetic and neurobiological aspects of the disorder[2].

Growth Projections

The ADHD market is projected to grow at a compound annual growth rate (CAGR) of 3.23% from 2024 to 2034, reaching USD 13.6 billion by 2034. Another estimate suggests a CAGR of 3.7% from 2024 to 2030, with the market size expected to be around USD 14.3 billion in 2023 and growing to USD 18.5 billion by 2030[2][5].

Regional Analysis

The United States has the largest patient pool for ADHD and represents the biggest market for its treatment. Other significant markets include Germany, France, the United Kingdom, Italy, Spain, and Japan. The robust demand for both pharmaceutical and non-pharmaceutical treatments in these regions drives market growth[2].

Advancements in Non-Stimulant Treatments

Focalin XR's Unique Delivery System

Focalin XR stands out due to its use of the SODAS® (Spheroidal Oral Drug Absorption System) technology, which releases 50% of the dose immediately and the remaining 50% gradually over several hours. This technology provides faster and more effective symptom control compared to traditional methylphenidate formulations like Concerta[2].

Key Players and Market Dynamics

Major Pharmaceutical Companies

Companies like Novartis, now part of Bristol-Myers Squibb, and other pharmaceutical giants are actively involved in the ADHD market. The resolution of shortages for medications like Vyvanse by Takeda has also ensured consistent availability, contributing to market stability and growth[2].

Efficacy and Safety

Clinical Efficacy

Clinical trials have consistently shown that Focalin XR is effective in reducing ADHD symptoms in both children and adults. For example, in a multicenter, double-blind, randomized, placebo-controlled study, patients treated with Focalin XR showed a statistically significant improvement in symptom scores compared to those receiving placebo[4].

Safety Profile

The safety profile of Focalin XR has been established through various clinical trials. While side effects can occur, the overall safety data support its use as a treatment for ADHD. The FDA has approved Focalin for the treatment of ADHD based on these comprehensive studies[3].

Conclusion

Focalin XR has been proven through clinical trials to be an effective treatment for ADHD in both pediatric and adult populations. The market for ADHD medications is growing, driven by increasing diagnoses and advancements in treatment technologies. With its unique delivery system and established efficacy, Focalin XR is poised to remain a significant player in the ADHD treatment market.

Key Takeaways

  • Clinical Efficacy: Focalin XR has shown significant improvements in ADHD symptoms in both children and adults through clinical trials.
  • Market Growth: The ADHD market is projected to grow at a CAGR of 3.23% to 3.7% from 2024 to 2034.
  • Unique Delivery System: Focalin XR uses the SODAS® technology, providing faster and more effective symptom control.
  • Safety Profile: The safety profile of Focalin XR is well-established through comprehensive clinical trials.
  • Market Dynamics: Major pharmaceutical companies are actively involved in the ADHD market, ensuring consistent availability of treatments.

FAQs

What is Focalin XR used for?

Focalin XR is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in both children and adults.

How does Focalin XR work?

Focalin XR uses the SODAS® technology to release 50% of the dose immediately and the remaining 50% gradually over several hours, providing faster and more effective symptom control.

What are the key findings from clinical trials of Focalin XR?

Clinical trials have shown that Focalin XR achieves statistically significant treatment effects compared to placebo in reducing ADHD symptoms in both children and adults.

What is the projected growth rate of the ADHD market?

The ADHD market is projected to grow at a CAGR of 3.23% to 3.7% from 2024 to 2034.

Which regions are the major markets for ADHD treatments?

The major markets include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan.

Sources

  1. FOCALIN Prescription & Dosage Information - eMPR.com
  2. Attention Deficit Hyperactivity Disorder Market Size to Reach USD 13.6 Billion by 2034 - Biospace
  3. Focalin - accessdata.fda.gov
  4. Focalin Statistical PREA - FDA
  5. Attention Deficit Hyperactivity Disorder Market Report, 2030 - Grand View Research

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