In the approvable letter, the FDA indicated that the label for Nuvigil will be affected by the outcome of its review of new information regarding a link between Cephalon’s investigational ADHD drug Sparlon and a possible case of Stevens Johnson syndrome.
Nuvigil’s active ingredient armodafinil is a formulation of modafinil, which is the active ingredient in Sparlon, as well as the company’s already approved sleep disorder medication, Provigil.
The company submitted a new drug application on March 31, 2005, seeking to market Nuvigil for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder.
In studies submitted to the FDA, Nuvigil was generally well tolerated, with a safety profile consistent with that observed in studies of Provigil. The most common adverse effects observed included headache, nausea, dizziness, insomnia and anxiety.
“We are working closely with the FDA to move this application to an approval and expand our offering of wake-promotion choices for patients,” said Dr Paul Blake, executive vice president of Cephalon’s worldwide medical and regulatory operations. “Based on the clinical trials, Nuvigil demonstrated a long duration of effect throughout the waking hours and we are excited at the potential to offer broader options to meet the needs of patients and physicians seeking treatment for excessive sleepiness.”