Nuvigil
Treatment for NarcolepsyUpdate: Nuvigil Now FDA Approved - June 15, 2007
Cephalon Files New Drug Application for Nuvigil
FRAZER, Pa., March 31, 2005 -- Cephalon, Inc. announced today that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration seeking approval to market Nuvigil (armodafinil) Tablets [C-IV] to improve wakefulness in patients suffering from excessive sleepiness associated with narcolepsy, shift work sleep disorder (SWSD) and obstructive sleep apnea/hypopnea syndrome (OSA/HS). Nuvigil is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in Provigil (modafinil) Tablets [C-IV].
The NDA is based on positive results of four double-blind, randomized, placebo-controlled studies of Nuvigil in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSA/HS. The data in this filing show that the primary endpoints of all studies were met and suggest that Nuvigil is differentiated from Provigil.
"This is the third of five FDA approvals that we will be pursuing over a 15-month time period," said Dr. Paul Blake, Executive Vice President, Worldwide Clinical Research & Regulatory Affairs at Cephalon. "Cephalon is a pioneer in developing compounds for improving wakefulness, and this on- schedule filing allows us to reinforce our leadership position in the treatment of disorders of sleep and wakefulness," added Dr. Blake.
About the Clinical Studies
In four, 12-week studies, daily doses of 150 and 250 milligrams of
Nuvigil or placebo were administered to approximately 1,000
patients with excessive sleepiness associated with either
narcolepsy, OSA/HS or SWSD. The primary endpoints in all studies
were measures of objective sleep latency (Maintenance of
Wakefulness Test or Multiple Sleep Latency Test) and the physician
rating of Clinical Global Impression-Change. In each study,
patients treated with Nuvigil showed a statistically significant
improvement on both primary endpoints compared to placebo (all p
values <0.05). Moreover, recordings and patient diaries showed
that compared with placebo, Nuvigil did not disturb patients'
normal sleep schedule.
In these Phase 3 studies, 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.
About Excessive Sleepiness
Excessive sleepiness is the primary symptom - and often the most
debilitating feature - patients experience with OSA/HS, SWSD and
narcolepsy. Associated with a reduction of activity in the cerebral
cortex of the brain, the defining characteristic of excessive
sleepiness is a consistent inability to stay awake and alert enough
to safely and successfully accomplish tasks of daily living. While
millions of Americans suffer from excessive sleepiness associated
with narcolepsy, OSA/HS and SWSD, they are often misdiagnosed and
the rate of underdiagnosis has been estimated to be between 50 to
90 percent. Persons experiencing excessive sleepiness who seek
medical attention typically complain of fatigue, tiredness, lapses
of attention, lack of energy, low motivation, difficulty
concentrating, disrupted sleep, snoring or difficulties at
work.
Cephalon, Inc.
Cephalon currently employs approximately 2,300 people in the United
States and Europe. U.S. sites include the company's corporate
headquarters in Frazer, Pennsylvania, and offices, laboratories or
manufacturing facilities in West Chester, Pennsylvania, Salt Lake
City, Utah, and suburban Minneapolis, Minnesota. Cephalon's
European offices are located in Guildford, England, Martinsried,
Germany, and Maisons-Alfort, France.
The company currently markets three proprietary products in the United States: Provigil, Gabitril (tiagabine hydrochloride) Tablets and Actiq (oral transmucosal fentanyl citrate) [C-II], and more than 20 products internationally. Further information about Cephalon and full prescribing information on its U.S. products is available at www.cephalon.com
Posted: March 2005
Related Articles
- Cephalon Receives FDA Approval of Nuvigil for the Treatment of Excessive Sleepiness Associated with Three Disorders - June 18, 2007
- Cephalon Provides Update Related to Nuvigil New Drug Application - April 2, 2007
- Cephalon Inc. Granted Composition of Matter Patent Covering Nuvigil - November 7, 2006
- Cephalon Receives Approvable Letter for Nuvigil - May 1, 2006
Nuvigil (armodafinil) FDA Approval History
