CLINICAL TRIALS PROFILE FOR NUVIGIL

All Clinical Trials for Nuvigil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00078325 ↗	Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)	Completed	Cephalon	Phase 3	2004-02-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12, or last post-baseline visit.
NCT00373672 ↗	Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder	Completed	Cephalon	Phase 4	2006-08-01	This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.
NCT00373672 ↗	Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 4	2006-08-01	This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.
NCT00373672 ↗	Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder	Completed	Vanderbilt University	Phase 4	2006-08-01	This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.
NCT00373672 ↗	Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder	Completed	Vanderbilt University Medical Center	Phase 4	2006-08-01	This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.

Clinical Trial Conditions for Nuvigil

Condition Name

Condition Name for Nuvigil
Intervention	Trials
Fatigue	7
Depression	4
Obstructive Sleep Apnea	3
Insomnia	2

Condition MeSH

Condition MeSH for Nuvigil
Intervention	Trials
Fatigue	12
Depression	4
Depressive Disorder, Major	4
Depressive Disorder	4

Clinical Trial Locations for Nuvigil

Trials by Country

Trials by Country for Nuvigil
Location	Trials
United States	146
Canada	5
Ukraine	4
Poland	3
Bulgaria	3

Trials by US State

Trials by US State for Nuvigil
Location	Trials
Texas	11
New York	9
California	8
Massachusetts	8
Pennsylvania	7

Clinical Trial Progress for Nuvigil

Clinical Trial Phase

Clinical Trial Phase for Nuvigil
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	8
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Nuvigil
Clinical Trial Phase	Trials
Completed	22
Terminated	5
Withdrawn	3

Clinical Trial Sponsors for Nuvigil

Sponsor Name

Sponsor Name for Nuvigil
Sponsor	Trials
Cephalon	13
National Cancer Institute (NCI)	7
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for Nuvigil
Sponsor	Trials
Other	34
Industry	21
NIH	9

NUVIGIL: Clinical Trials, Market Analysis, and Projections

Introduction to NUVIGIL

NUVIGIL, also known as armodafinil, is a wakefulness-promoting agent used primarily to treat excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Nuvigil and Provigil Pregnancy Registry

One significant clinical trial related to NUVIGIL is the Nuvigil and Provigil Pregnancy Registry. This observational study, conducted by Teva Pharmaceuticals, aimed to characterize the pregnancy and fetal outcomes associated with exposure to NUVIGIL (armodafinil) and PROVIGIL (modafinil) during pregnancy. The study, which ran from June 30, 2009, to November 30, 2023, was terminated but provided valuable insights into the safety profile of these medications during pregnancy[1].

Armodafinil for Fatigue in Malignant Gliomas

Another notable trial is the randomized placebo-controlled trial of armodafinil for treating fatigue in patients with malignant gliomas undergoing radiotherapy with or without standard chemotherapy. This study, conducted by Dana-Farber, aims to determine the safety and efficacy of armodafinil in reducing radiation-induced fatigue in brain tumor patients. The trial includes patients with histologically confirmed malignant glioma and assesses various inclusion and exclusion criteria to ensure the safety and relevance of the study[4].

Market Analysis

Current Market Size and Growth

The armodafinil market, which includes NUVIGIL, has seen significant growth driven by increasing awareness of sleep disorders and the demand for cognitive enhancers. As of 2023, the market size for armodafinil has reached approximately $1.1 billion, with North America holding a substantial share due to advanced healthcare infrastructure and rising healthcare expenditure[5].

Geographic Distribution

The market is primarily concentrated in North America, with the United States being the largest consumer. Canada follows, albeit at a slower growth rate. In Europe, Germany and the U.K. are notable markets, influenced by robust healthcare systems and increasing awareness of wakefulness-promoting agents. The Asia-Pacific region, particularly China and India, is the fastest-growing, spurred by rising healthcare expenditures and shifting cultural attitudes toward mental health[5].

Key Players and Market Share

The armodafinil market is characterized by a competitive landscape dominated by major pharmaceutical companies. Teva emerges as a market leader, holding approximately 25% market share, followed by Mylan and Apotex with around 20% and 15% respectively. Emerging challengers like Aurobindo and Natco Pharma are also making significant strides by targeting niche segments and enhancing product differentiation[5].

Market Projections

Growth Forecast

The armodafinil market is projected to exhibit a Compound Annual Growth Rate (CAGR) of 4.50% during the forecast period from 2024 to 2031. This growth is driven by ongoing research, the introduction of generic drugs, and an evolving regulatory landscape that fosters greater accessibility to treatment options[5].

Drivers of Growth

Key drivers of this growth include the increasing prevalence of sleep disorders, the growing recognition of cognitive enhancers, and lifestyle changes leading to heightened stress and sleep deprivation. The rising number of product launches and clinical trials, along with the increasing incidence of narcolepsy in adults, are also significant factors contributing to market growth[3][5].

Challenges and Trends

Despite the positive outlook, the market faces challenges such as low awareness of narcolepsy symptoms and stringent regulations that may impede growth. However, trends like advancements in narcolepsy treatment, increasing demand for non-pharmacological therapies, and a growing preference for combination treatments are expected to fuel market growth during the forecast period[3].

Market Size and Revenue Projections

The narcolepsy drugs market, which includes NUVIGIL, is projected to grow by USD 1.60 billion from 2021 to 2026, at a CAGR of 9.1%. North America is expected to contribute 44% of this market growth, particularly in the US and Canada[3].

Key Takeaways

• Clinical Trials: Ongoing and completed trials, such as the Nuvigil and Provigil Pregnancy Registry and the trial on armodafinil for fatigue in malignant gliomas, provide valuable data on the safety and efficacy of NUVIGIL.
• Market Size: The armodafinil market has reached approximately $1.1 billion as of 2023, with North America being the largest market.
• Growth Forecast: The market is projected to grow at a CAGR of 4.50% from 2024 to 2031.
• Key Players: Teva, Mylan, and Apotex are major players, with emerging companies like Aurobindo and Natco Pharma making significant contributions.
• Drivers and Challenges: Increasing prevalence of sleep disorders, growing recognition of cognitive enhancers, and regulatory environments are key drivers, while low awareness and stringent regulations are challenges.

FAQs

What is NUVIGIL used for?

NUVIGIL (armodafinil) is used to treat excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work sleep disorder.

What is the current market size of the armodafinil market?

As of 2023, the armodafinil market size has reached approximately $1.1 billion.

Who are the major players in the armodafinil market?

Teva, Mylan, and Apotex are the major players, with Teva holding around 25% market share.

What is the projected growth rate of the armodafinil market?

The armodafinil market is projected to exhibit a CAGR of 4.50% from 2024 to 2031.

What are the key drivers of growth in the armodafinil market?

Key drivers include the increasing prevalence of sleep disorders, growing recognition of cognitive enhancers, and ongoing research and product launches.

Sources

1. Teva Pharmaceuticals: Nuvigil and Provigil Pregnancy Registry.
2. Sleep Review: Mylan Launches Generic of Nuvigil Tablets.
3. Technavio: Narcolepsy drugs market size to increase by USD 1.60 billion from 2021 to 2026.
4. Dana-Farber: A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) For Fatigue in Patients with Malignant Gliomas Undergoing Radiotherapy With or Without Standard Chemotherapy Treatment.
5. OpenPR: Comprehensive Growth Forecast for Armodafinil Market: Segmentation Analysis and Market Trends (2024 - 2031).

Last updated: 2025-01-02