Cephalon, Inc. has received an approvable letter from the US FDA for Nuvigil (armodafinil) Tablets. The company submitted a new drug application (NDA) on March 31, 2005, seeking to market Nuvigil for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSA/HS) and shift work sleep disorder (SWSD). FDA approval of Nuvigil is contingent upon finalizing the product label.
"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, 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," he added.
Armodafinil is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in Provigil (modafinil) Tablets [C-IV]. Cephalon submitted data from four double-blind, randomized, placebo-controlled studies of Nuvigil in patients with excessive sleepiness associated with either narcolepsy, OSA/HS or SWSD to FDA for evaluation as part of the NDA. In these studies, Nuvigil was generally well tolerated, with a safety profile consistent with that observed in studies of Provigil, stated the release.
As previously announced, the company submitted additional information to the FDA related to a possible case of Stevens Johnson Syndrome associated with its Sparlon (modafinil) application. In its Nuvigil approvable letter, the FDA indicated that the outcome of its review of this new information will be addressed directly in the label for Nuvigil.
Excessive sleepiness, medically known as hypersomnolence, is the primary symptom -- and often the most debilitating feature -- experienced by the millions of Americans who suffer from narcolepsy, OSA/HS, and SWSD. Despite this fact, it is estimated that 50 to 90 percent of the time, health care professionals fail to recognize that these patients are suffering from excessive sleepiness.