CLINICAL TRIALS PROFILE FOR FOCALIN XR

All Clinical Trials for FOCALIN XR

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.

Clinical Trial Conditions for FOCALIN XR

Condition Name

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

Condition MeSH

Condition MeSH for FOCALIN XR
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	6
Hyperkinesis	4
Disease	2
Mood Disorders	1

Clinical Trial Locations for FOCALIN XR

Trials by Country

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−

Trials by Country for FOCALIN XR
Location	Trials
United States	14
Switzerland	1

Trials by US State

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−

Trials by US State for FOCALIN XR
Location	Trials
Massachusetts	3
Missouri	2
Nevada	1
Florida	1
Arkansas	1

Clinical Trial Progress for FOCALIN XR

Clinical Trial Phase

Clinical Trial Phase for FOCALIN XR
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for FOCALIN XR
Clinical Trial Phase	Trials
Completed	11
Recruiting	1

Clinical Trial Sponsors for FOCALIN XR

Sponsor Name

Sponsor Name for FOCALIN XR
Sponsor	Trials
Massachusetts General Hospital	3
Teva Pharmaceuticals USA	2
Novartis	1

Sponsor Type

Sponsor Type for FOCALIN XR
Sponsor	Trials
Other	10
Industry	5
NIH	1

FOCALIN XR: Clinical Trials, Market Analysis, and Projections

Introduction

FOCALIN XR, a extended-release formulation of dexmethylphenidate, is a central nervous system (CNS) stimulant used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and adult patients. Here, we will delve into the clinical trials that have established its efficacy, analyze its market position, and discuss projections for its future in the ADHD treatment market.

Clinical Trials: Pediatric Patients

Study 1: Randomized, Double-Blind, Placebo-Controlled Trial

In a pivotal study involving 103 pediatric patients aged 6 to 17, FOCALIN XR demonstrated significant efficacy. Patients were randomly assigned to receive either a flexible dose of FOCALIN XR (5 to 30 mg/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 showed 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][4].

Studies 2 and 3: Crossover Studies

Two crossover studies involving pediatric patients aged 6 to 12 years further supported the efficacy of FOCALIN XR. In these studies, patients received either FOCALIN XR 20 mg or placebo. The Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) rating scale total scores showed statistically significant treatment effects at all time points after dosing, indicating rapid and sustained efficacy[1][4].

Clinical Trials: Adult Patients

Study 4: Randomized, Double-Blind, Placebo-Controlled Trial

In a study involving 221 adult patients aged 18 to 60, FOCALIN XR was evaluated for its efficacy in treating ADHD. Patients were randomly assigned to receive either a flexible dose of FOCALIN XR (20, 30, or 40 mg/day) or placebo once daily for 5 weeks. 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). All three doses of FOCALIN XR achieved statistically significant treatment effects compared to placebo[1][4].

Safety and Side Effects

FOCALIN XR, like other CNS stimulants, has several safety considerations. It has a high potential for abuse and misuse, which can lead to substance use disorder, including addiction. Other notable side effects include priapism, peripheral vasculopathy (including Raynaud’s Phenomenon), and long-term suppression of growth in pediatric patients. Careful monitoring of growth, cardiac health, and signs of abuse or misuse is recommended[2].

Market Analysis

Current Market Position

FOCALIN XR is a significant player in the ADHD treatment market, particularly noted for its efficacy in both children and adults. It offers an alternative to traditional methylphenidate formulations and has been shown to provide faster and more effective symptom control compared to some other extended-release formulations like Concerta. The use of SODAS® (Spheroidal Oral Drug Absorption System) technology allows for immediate release of 50% of the dose, followed by gradual release of the remaining 50% over several hours, enhancing its pharmacokinetic profile[5].

Market Projections

The ADHD market is expected to grow significantly, reaching USD 13.6 billion by 2034 with a Compound Annual Growth Rate (CAGR) of 3.23% during 2024-2034. FOCALIN XR, with its established efficacy and unique delivery system, is well-positioned to capture a substantial share of this growing market. The involvement of major pharmaceutical companies like Novartis (now part of Sandoz) further supports its market presence and potential for continued growth[5].

Competitive Landscape

FOCALIN XR competes in a market dominated by various ADHD medications, including both stimulant and non-stimulant options. However, its unique formulation and rapid onset of action make it a preferred choice for many patients and healthcare providers. The ongoing development and approval of new ADHD treatments will continue to shape the competitive landscape, but FOCALIN XR's established efficacy and safety profile ensure its relevance in the market[5].

Conclusion

FOCALIN XR has demonstrated robust efficacy in clinical trials for both pediatric and adult patients with ADHD. Its safety profile, while requiring careful monitoring, aligns with other CNS stimulants. The market projections indicate a strong future for FOCALIN XR, driven by its unique pharmacokinetic properties and the growing demand for effective ADHD treatments.

Key Takeaways

• Efficacy in Clinical Trials: FOCALIN XR has shown statistically significant treatment effects in both pediatric and adult patients with ADHD.
• Safety Considerations: High potential for abuse, priapism, peripheral vasculopathy, and long-term suppression of growth in pediatric patients.
• Market Position: A significant player in the ADHD treatment market, offering faster and more effective symptom control.
• Market Projections: Expected to benefit from the growing ADHD market, reaching USD 13.6 billion by 2034.
• Competitive Landscape: Competes with various ADHD medications but stands out due to its unique formulation and rapid onset of action.

FAQs

What is FOCALIN XR used for?

FOCALIN XR is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and adult patients.

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

Clinical trials have shown that FOCALIN XR achieves statistically significant treatment effects compared to placebo in both pediatric and adult patients, as measured by various rating scales such as CADS-T and DSM-IV ADHD RS.

What are the potential side effects of FOCALIN XR?

Potential side effects include high potential for abuse and misuse, priapism, peripheral vasculopathy, and long-term suppression of growth in pediatric patients.

How does FOCALIN XR compare to other ADHD medications?

FOCALIN XR provides faster and more effective symptom control compared to some other extended-release formulations like Concerta, thanks to its SODAS® technology.

What are the market projections for FOCALIN XR?

The ADHD market, including FOCALIN XR, is expected to grow to USD 13.6 billion by 2034, with a CAGR of 3.23% during 2024-2034.

Sources

1. FOCALIN Prescription & Dosage Information - MPR - eMPR.com
2. FOCALIN XR - accessdata.fda.gov
3. 212994Orig1s000 - accessdata.fda.gov
4. FOCALIN XR Prescription & Dosage Information - MPR - eMPR.com
5. Attention Deficit Hyperactivity Disorder Market Size to Reach USD 13.6 Billion by 2034 - Biospace.com