Approval of expanded label for Provigil to treat excessive sleepiness
WEST CHESTER, PA., January 26, 2004 -- Cephalon, Inc. announced that it has received approval from the FDA to market Provigil (modafinil) [C-IV] Tablets to improve wakefulness in patients with excessive sleepiness (ES) associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).
In 1998, Provigil became the first in a new class of wake-promoting agents approved in the United States for improving wakefulness in patients with narcolepsy. For patients with OSAHS, Provigil is approved as an adjunct to standard treatment for the underlying airway obstruction.
"The approval of Provigil for these conditions provides clinicians with a therapeutic option to treat the debilitating excessive sleepiness that affects the daily lives of patients with obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder," said Paul Blake, MB, FRCP, Senior Vice President of Clinical Research and Regulatory Affairs at Cephalon. "The favorable safety profile of Provigil in studies involving more than 3,500 patients should allow physicians to confidently prescribe the drug."
Joseph Lieberman, MD, MPH, Professor of Family Medicine, Jefferson Medical College, Philadelphia, added: "Currently, many patients suffer needlessly from excessive sleepiness because they simply don't recognize it as a symptom of a medical condition and therefore don't talk to their doctors about it. Primary care physicians are in a position to identify excessive sleepiness and initiate appropriate diagnosis and care of their patients, including educating them about the dangers of engaging in certain activities while impaired by excessive sleepiness. Now with the approval of Provigil, we have a new treatment option for our patients -- when they have been appropriately diagnosed and treatment of their underlying condition does not resolve their excessive sleepiness."
Provigil promotes wakefulness in pre-clinical studies without causing generalized stimulation in the brain. The drug is believed to work selectively through the sleep/wake centers to activate the cortex of the brain. Activation of the cortex is essential for wakefulness. The exact mechanism of action of Provigil is not known.
The safety of Provigil has been demonstrated in clinical trials enrolling more than 3,500 patients. In studies of OSAHS and SWSD, the overall safety profile of Provigil was demonstrated to be consistent with the profile already established in patients with narcolepsy.
Provigil has been shown to have no effect on the patient's ability to sleep when sleep is desired. Studies have demonstrated that the sleep of patients taking Provigil was of similar quality and quantity to individuals on placebo. In clinical trials, Provigil was well tolerated, with an incidence of adverse events generally comparable to placebo. Most adverse events were mild to moderate. The most frequently reported adverse events were headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, trouble sleeping, dizziness and upset stomach.
Launched in the United States in February 1999, Provigil currently is approved in more than 20 countries. Provigil is supplied as oral tablets containing either 100 mg or 200 mg of modafinil. The recommended dose of Provigil is 200 mg once daily. For patients with narcolepsy and OSAHS, Provigil should be taken as a single dose in the morning. Patients with SWSD should take Provigil approximately one hour prior to the start of their work shift. For full prescribing information, visi
Posted: January 2004