If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Provigil Offers Significant Benefit In Reducing Excessive Daytime Sleepiness WEST CHESTER, PA -- February 3, 2000 -- Cephalon, Inc. announced that results from a 157-patient, double-blind, placebo-controlled study in patients suffering from excessive daytime sleepiness (EDS) associated with obstructive sleep apnea demonstrated that Provigil(R) (modafinil) Tablets [C-IV] increased daytime wakefulness in patients being treated with continuous positive airway pressure (CPAP). Based upon these positive findings, Cephalon has initiated an additional clinical trial with Provigil in patients with obstructive sleep apnea with the intention of pursuing a label extension to include this additional indication.
Results of this multi-center, parallel group study indicate that patients being treated with Provigil performed better on validated tests of wakefulness. Provigil had a statistically significant benefit in reducing excessive daytime sleepiness (EDS) as measured by the Epworth Sleepiness Scale (ESS), the primary endpoint in the study, and the multiple sleep latency test (MSLT). The most common side effects potentially attributable to Provigil in this study were headache, nervousness, rhinitis, nausea, anxiety and dizziness. Results of this study are expected to be presented at the World Congress on Sleep Apnea in Sydney, Australia in March. Obstructive sleep apnea is a serious and potentially life-threatening sleep disorder that according to the National Institutes of Health afflicts more than 8 million Americans. However, only approximately one million individuals are currently diagnosed and treated. Individuals with obstructive sleep apnea experience frequent awakenings, sometimes occurring hundreds of times during the night, as a result of blockage of the airway during sleep. The most common treatment for obstructive sleep apnea is CPAP, although even with treatment many of these patients still suffer from significant EDS. Cephalon recently reported positive findings from a clinical study with Provigil in patients experiencing fatigue associated with multiple sclerosis, and with Provigil in a simulated shift work study. In addition, the Company is conducting clinical studies with Provigil in adults with attention deficit/hyperactivity disorder (ADHD) and patients with excessive daytime sleepiness resulting from sleep disorders or fatigue associated with certain neurological diseases. Cephalon currently markets Provigil in several countries, including the United States, for the treatment of excessive daytime sleepiness associated with narcolepsy. The most common side effects associated with Provigil in treating EDS associated with narcolepsy include nausea, infection, nervousness, anxiety and insomnia. Related Links: Provigil (modafinil) and Cephalon, Inc.
|
