Drug Development

New drug application filed for narcolepsy therapy Nuvigil

Published in Drug Week, May 6th, 2005

Cephalon, Inc., (CEPH) 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...

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Source: Drug Week (2005-05-06)

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