Sleep Blog

New medication approved to help battle excessive sleepiness

related to sleep apnea, narcolepsy, shift-work sleep disorder

FRAZER, PA. (June 18) — Cephalon, Inc. announced it has received approval from the U.S. Food and Drug Administration to market Nuvigil (armodafinil) tablets [C- IV], 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 treating obstructive sleep apnea, the company says Nuvigil can work as an adjunct to standard treatment, such as CPAP or BiPAP, in treating the underlying obstruction. Nuvigil is the single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in Provigil (modafinil) Tablets [C-IV], which was approved by FDA in 1998 to improve wakefulness.

“FDA approval of Nuvigil is a major accomplishment and the result of collaborative efforts with the scientific and regulatory communities,” said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. “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.”

Cephalon, founded in 1987 and based in Frazer, Pennsylvania, will evaluate the use of Nuvigil as a treatment for serious medical conditions such as 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., Ph.D., Chairman and CEO, Cephalon. “More importantly, we now have a longer-term opportunity to further characterize the utility of this compound beyond wakefulness.” Nuvigil is protected by a U.S. patent expiring in 2023.

The agency has approved final labeling for Nuvigil, including a bolded warning, which is consistent with the draft labeling received by the company in March 2007. Full prescribing information will eventually be posted on the FDA’s site, but is currently posted on Cephalon’s site. The FDA also has indicated that it will request similar language in the label for Provigil.

The active pharmaceutical ingredient in Nuvigil, armodafinil, is the longer-lived r-enantiomer of modafinil, the active ingredient in Provigil. The approval of Nuvigil is based on positive results of four double-blind, randomized, placebo-controlled studies in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSAHS. In these studies, Nuvigil was generally well tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.

The company’s proprietary products in the United States include: Provigil, Fentora (fentanyl buccal tablet) [C-II], Trisenox (arsenic trioxide) injection, Vivitrol (naltrexone for extended-release injectable suspension), Gabitril (tiagabine hydrochloride), and Actiq (oral transmucosal fentanyl citrate) [C-II].

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