Cephalon Files Modafinil Application In USA

US biopharmaceutical company Cephalon Inc has now filed a New DrugApplication with the US Food and Drug Administration for marketing approval of modafinil, its treatment for excessive daytime sleepiness associated with narcolepsy.

Modafinil was discovered by the French company Laboratoire Lafon, which has granted exclusive marketing rights to Cephalon for the USA, Japan, the UK, Ireland and Mexico. It is already approved and marketed in France for the treatment of narcolepsy and idiopathic hypersomnia.

The FDA submission contains results of 14 clinical trials with modafinil conducted by Cephalon, including two double-blind, placebo-controlled Phase III studies involving 558 patients with narcolepsy. The Phase III studies were conducted at 39 sleep centers in the USA and were designed to assess the patient's ability to stay awake using a number of laboratory and clinical measures. The studies also measured the patient's well-being, as assessed by an independent clinician, and the patient's quality of life.