Cephalon Inc, Frazer, Penn, has received FDA approval to market Nuvigil, a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder (SWSD).
In OSAHS, Nuvigil is indicated as an adjunct to standard treatment for the underlying obstruction. Nuvigil is the single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in Provigil, which was approved by FDA in 1998 to improve wakefulness.
“We are excited about the future of Nuvigil and we have initiated additional clinical work to explore its potential in a wide range of medical disorders,” said said Dr. Lesley Russell, executive vice president, Worldwide Medical and Regulatory Operations.
Cephalon’s clinical program will evaluate a much more broad use of Nuvigil as a treatment for bipolar depression, cognition associated with schizophrenia, excessive sleepiness in medical conditions such as Parkinson’s disease, and fatigue in patients who are being treated for cancer. The company currently plans a commercial launch of Nuvigil once additional clinical data has been amassed.
“The approval of Nuvigil allows us to preserve our current leadership position in the area of wakefulness,” said Frank Baldino, Jr., PhD, chairman and CEO, Cephalon. “More importantly, we now have a longer-term opportunity to further characterize the utility of this compound beyond wakefulness.”