Pharmaprojects R&D Pipeline News Feed
Cephalon wins US approval for new sleep disorder treatment
19 Jun 2007
Cephalon has been granted US FDA approval to market Nuvigil (armodafinil) for the treatment of excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome, narcolepsy, and shift work sleep disorder. Nuvigil is the single-isomer formulation of modafinil, the active ingredient in Cephalon's first non-amphetamine wake-promoting agent Provigil.
In Phase III clinical trials, Cephalon found treatment with Nuvigil was well tolerated and resulted in significantly improved levels of wakefulness and quality of episodic memory. Minor adverse effects experienced by patients were headache, diarrhoea, nausea, dizziness and anxiety. Clinical trials are underway to assess the potential of Nuvigil for the treatment of a wide range of neurological disorders, including bipolar depression and sleepiness associated with conditions such as Parkinson's disease.
Nuvigil will be available alongside other current treatment options, including stimulants such as Provigil and Xyrem (sodium oxybate) which aim at reducing excessive daytime sleepiness in sufferers.
