Cephalon Inc has filed a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration requesting marketing approval of Provigil (modafinil) Tablets [C-IV] for the treatment of excessive sleepiness associated with disorders of sleep and wakefulness in adults.
Excessive sleepiness is a common consequence of disorders of sleep and wakefulness. The disorders of sleep and wakefulness associated with excessive sleepiness can be categorized on the basis of their primary underlying pathology. To support the label expansion requested in the sNDA, Cephalon studied excessive sleepiness associated with several representative disorders of sleep and wakefulness:
*Disorders of sleep-wake cycle regulation associated with central nervous system disease, represented by narcolepsy
*Sleep disruption, represented by obstructive sleep apnea
*Circadian misalignment, represented by shift work sleep disorder
The sNDA is based on positive data from six double-blind, placebo- controlled clinical studies evaluating the safety and effectiveness of Provigil versus placebo in more than 1,500 patients with excessive sleepiness associated with a disorder of sleep and wakefulness.
"For the patients who suffer from excessive sleepiness as a result of a disorder of sleep and wakefulness, this application is a milestone in nearly 10 years of research to address this unmet medical need," said Dr. Paul Blake, Senior Vice President of Clinical Research and Regulatory Affairs at Cephalon. "Cephalon looks forward to the review of Provigil data by the FDA for this expanded use." The FDA's targeted review period for standard sNDAs is 10 to 12 months.
Provigil is the first in a new class of wake-promoting agents and is currently approved in more than 20 countries for the treatment of excessive daytime sleepiness associated with narcolepsy. Earlier this month, Cephalon received approval to market Provigil to treat excessive daytime sleepiness in patients with obstructive sleep apnea/hypopnea syndrome in the United Kingdom.
In controlled clinical trials, Provigil has been found to be generally well tolerated with a low incidence of adverse events relative to placebo. The most commonly observed adverse events associated with the use of Provigil were headache, infection, nausea, nervousness, anxiety and insomnia.