By Mark Chael ---
On March 30, 2007, Cephalon, Inc. announced that it had received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding Cephalon's Nuvigil® (armodafinil) new drug application (NDA). The approvable letter was accompanied by draft labeling that includes a proposed warning section in bold type describing a potential occurrence of skin rash and hypersensitivity. In the approvable letter, the FDA requested the standard safety update from clinical trials (the previous update was provided in June, 2006) as well as samples of introductory marketing materials for Nuvigil® tablets. Importantly, the FDA has not required any additional clinical or scientific studies for final approval.
Once finally approved, Nuvigil® will be a C-IV controlled substance prescribed for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), and shift work sleep disorder (SWSD). Armodafinil is an optically active enantiomer of modafinil, which is the active ingredient in Provigil®, Cephalon's currently marketed drug for the same condition. Apparently, at least one advantage of armodafinil over modafinil is its longer duration of effect. U.S. Patent No. 7,132,570, assigned to Cephalon, discloses crystalline forms of optical enantiomers of modafinil and methods for their production. Also, U.S. Patent Publication No. 2006/0086667, assigned to Cephalon, discloses methods for the separation of enantiomeric sulfinylacetamides (e.g., armodafinil).
Cepholon's March 31, 2005 press release announcing the filing of the Nuvigil® NDA can be found here.
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