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FDA Approves of Expanded Labelling of Provigil (Modafinil), Previously Approved for Treatment of Narcolepsy

First Drug Approved to Treat Excessive Sleepiness Associated with Obstructive Sleep Apnea/Hypopnea Syndrome and Excessive Sleepiness Associated with Shift Work Sleep Disorder

WEST CHESTER, PA -- January 26, 2004 -- Cephalon, Inc. (Nasdaq: CEPH) today announced that it has received approval from the U.S. Food and Drug Administration (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," Dr. Blake added.

Frank Baldino, Chairman and CEO of Cephalon, said: "This new label allows us to bring Provigil to millions of new patients and thousands of new prescribers. We believe this will have a positive impact on the company's performance."

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

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.

Excessive Sleepiness

Excessive sleepiness (ES) is the primary symptom -- and often the most debilitating feature -- associated with obstructive sleep apnea / hypopnea syndrome (OSAHS), shift work sleep disorder (SWSD) and narcolepsy. ES is defined as difficulty in maintaining wakefulness and an increased likelihood of falling asleep in inappropriate situations.

Obstructive Sleep Apnea/Hypopnea Syndrome

In OSAHS, sleep disruption is most commonly caused by airway obstruction -- usually the relaxation and collapse of the soft tissue in the back of the throat during sleep. Symptoms of OSAHS may include restless sleep, loud, heavy snoring (often interrupted by silence and then gasps), falling asleep during the day (at work, watching TV, etc.), morning headaches, loss of energy, trouble concentrating, irritability, forgetfulness, mood or behavior changes, anxiety or depression, and obesity. According to the National Institutes of Health, approximately 12 million Americans suffer from OSAHS, which is twice as common in men as in women.

Continuous positive airway pressure or CPAP, a medical device that blows air through the nasal passage, is the primary treatment for OSAHS. Despite adequate regular use of CPAP, many patients continue to experience excessive sleepiness. For these patients, Provigil may be an appropriate adjunctive treatment.

Shift Work Sleep Disorder

SWSD is defined as a persistent or recurrent pattern of sleep disruption leading to excessive sleepiness or insomnia that is due to a mismatch between the sleep-wake schedule required by a person's environment and his or her circadian sleep-wake pattern. Characterized by extreme sleepiness, insomnia, headaches and difficulty concentrating, SWSD can affect those who frequently rotate shifts or work at night. Six million people in the United States work permanent or rotating night shifts and therefore are at risk for SWSD.

Full Prescribing Information Available

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 please visit http://www.provigil.com or call 1-800-896-5855.


SOURCE: Cephalon, Inc.

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