Cephalon Inc, Frazer, Pa, has finalized revisions to the label for Provigil (modafinil), its wake-promoting agent.
As the company announced earlier this year, the changes were necessary to make the Provigil label consistent with the Nuvigil™ (armodafinil) label approved by the FDA last June. Nuvigil is the single isomer formulation of modafinil, the active ingredient contained in Provigil.
Provigil and Nuvigil are indicated to improve wakefulness in patients with sleep apnea, shift work sleep disorder, and narcolepsy. In obstructive sleep apnea-hypopnea syndrome (OSAHS), both drugs are indicated as adjuncts to standard treatment(s) for the underlying obstruction. Neither drug is approved for children.
Cephalon is currently testing Nuvugil’s potential beyond sleep disorder prevention including treatment for psychiatric and neurological medical conditions as reported in the July 24, 2007 edition of Sleep Review’s online news. The company currently plans a commercial launch of Nuvigil after further clinical data has been gathered.
To read the full press release, click here.