US company, Cephalon, received a boost late last week after reporting promising Phase III data from a clinical trial of Nuvigil (armodafinil) in patients suffering from one of three types of sleep disorder.

The 12-week trials tested the 150mg and 250mg doses of the drug in around 1,000 patients suffering from either excessive sleepiness associated with narcolepsy, shift work sleep disorder, or obstructive sleep apnea/hypopnea syndrome, and found that Nuvigil “significantly improves wakefulness and the overall clinical condition of patients as compared to placebo.” The firm says that the studies also showed that Nuvigil promotes wakefulness later in the day without impairing sleep, establishing its long duration of action.

Full data will be presented later this year, and Cephalon hopes to be in a position to file the drug with the US Food and Drug Administration this quarter. “We expect to deliver a filing that highlights the safety and efficacy of Nuvigil for these patient populations and demonstrates clinical improvements in fatigue and cognition, as well as a long duration of action without affecting the patient’s normal sleep schedule,” said Dr Paul Blake, senior vice president, clinical research and regulatory affairs, at Cephalon.

- In other news, Mylan Laboratories says that it has won tentative FDA approval for its generic version of Cephalon’s narcolepsy treatment, Provigil (modafinil).