Cephalon Inc has received marketing approval from the Medicines Control Agency (MCA) in the United Kingdom to expand the label of Provigil (modafinil) to treat excessive daytime sleepiness in patients with obstructive sleep apnea/hypopnea syndrome.The 200 mg tablet of Provigil was also approved, in addition to the 100 mg dosage currently available in this territory.Cephalon UK Limited will officially launch the new indication at a symposium during the British Thoracic Society meeting being held December 4-6 in London.

"We are pleased that the data used to support this label expansion was accepted by the UK regulatory authority," said Paul Blake, Senior Vice President of Clinical Research and Regulatory Affairs at Cephalon. "Achievement of this milestone will enable us to grow the market for modafinil in the United Kingdom and sets the stage for regulatory submissions in other European countries over the next year."

The UK approval is the first of two regulatory milestones that Cephalon expects to achieve this year for Provigil.Cephalon intends to file an application with the U.S. Food and Drug Administration at year-end seeking to expand the label of PROVIGIL to include treatment of excessive sleepiness associated with sleep disorders beyond narcolepsy.

Modafinil 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. Provigil was initially launched in the UK in 1998 for the treatment of narcolepsy.

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.

Obstructive sleep apnea/hypopnea syndrome is a serious and potentially life-threatening sleep disorder affecting four percent of middle-aged men and two percent of middle-aged women.Individuals with obstructive sleep apnea hypopnea syndrome experience frequent awakenings throughout the night as a result of blockage of the airway during sleep.This disruption of sleep leads to excessive daytime sleepiness causing many people to doze off repeatedly throughout the day -- at their jobs and at home.

The most commonly used standard treatment is continuous positive airway pressure (CPAP).A nasal CPAP device can prevent airway closure while in use, but despite this treatment many patients continue to experience residual excessive sleepiness.