Modafinil Filed In Canada By End-96?

Draxis Health, the firm which holds Canadian rights to the narcolepsy drug modafinil, expects to file for approval of the drug by year-end. Modafinil was originally developed by France's Lafon, and is licensed by Cephalon in the USA, the UK and Japan (Marketletters passim).

Draxis has reported the results of a 75-patient study of modafinil, which reveals that in patients who had received no prior treatment with stimulants, a decrease in daytime sleepiness was reported in 80% of those taking modafinil 400mg/day, 66% of those taking 200mg/day and 34% of those on placebo. In previously-treated patients, the values were 53%, 50% and 25% respectively.

Modafinil was found to have no adverse effects on mood, with a single exception. At the 400mg/day dose, the drug increased tension-anxiety compared to placebo. However, the scores were still well below pre-study values. Vigor-activity scores were increased by modafinil.