Provigil^® (modafinil) Tablets (C-IV)

Supplemental NDA

 

 

Briefing Document

For

Peripheral and Central Nervous System Drugs

Advisory Committee Meeting

 

 

25 September 2003

 

 

 

Sponsor

Cephalon, Inc.
145 Brandywine Parkway
West Chester, Pennsylvania 19380
USA

 

 

 

 

 

 

 

 

PROVIGIL is a registered trademark of Genelco, S.A., licensed to Cephalon, Inc.

TABLE OF CONTENTS

                                                                                                                                             Page

List of Figures. 4

List of Tables. 4

list of abbreviations and deffinitionS of terms. 4

1     NEW INDICATION FOR PROVIGIL: EXCESSIVE SLEEPINESS ASSOCIATED WITH DISORDERS OF SLEEP AND WAKEFULNESS. 4

2     review of excessive sleepiness and disorders of sleep and wakefulness. 4

2.1     Introduction. 4

2.2     Normal and Excessive Sleepiness. 4

2.2.1     Physiology of Normal sleepiness. 4

2.2.2     Excessive Sleepiness. 4

2.3     Sleep Disorders. 4

2.3.1     International Classification of Sleep Disorders (ICSD). 4

2.3.2     ICSD Differential Diagnosis of Excessive Sleepiness. 4

2.4     Excessive Sleepiness Associated With Disorders of Sleep and Wakefulness. 4

2.4.1     Categorization of Disorders of Sleep and Wakefulness. 4

2.4.2     Excessive Sleepiness Associated With Disorders of Sleep‑Wake Dysregulation. 4

2.4.3     Excessive Sleepiness Associated With Disorders of Sleep Disruption. 4

2.4.4     Excessive Sleepiness Associated With Disorders of Circadian Misalignment 4

2.4.5     Appropriateness of Models Used in the Clinical Program.. 4

2.5     Manifestations and Consequences of Excessive Sleepiness Associated With Disorders of Sleep and Wakefulness. 4

2.6     Excessive Sleepiness, Sleep, and Quality-of-Life Measures. 4

2.6.1     Excessive Sleepiness. 4

2.6.1.1     Objective Measures. 4

2.6.1.2     Subjective Measures. 4

2.6.2     Sleep. 4

2.6.3     Quality‑of‑Life Measures and Functional Outcomes. 4

2.6.4     Overview of Measures of Excessive Sleepiness. 4

2.7     Excessive Sleepiness Treatment Considerations. 4

2.8     Overall Summary. 4

3     Pharmacology of modafinil.. 4

4     Study designs, patient populations, and efficacy and QUALITY‑Of‑Life results. 4

4.1     Overview of Stud