Cephalon, Inc. announced that it has received approval from the US 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."