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Phase III Trials Initiated for the R-Isomer of Modafinil
WEST CHESTER, Pa., Jan. 13 /PRNewswire-FirstCall/ -- Cephalon, Inc. announced today, at the JP Morgan Healthcare Conference, data from its earlier clinical trials with R-modafinil and information about the Phase III clinical program for the compound that the company initiated in December 2003. R-modafinil, a single-isomer of the active pharmaceutical ingredient contained in PROVIGIL® (modafinil) Tablets [C-IV], is initially being developed for the treatment of excessive sleepiness associated with narcolepsy and obstructive sleep apnea/hypopnea syndrome (OSA/HS).
The efficacy portion of the Phase III program with R-modafinil consists of 2 twelve-week clinical trials in patients with OSA/HS and one in patients with narcolepsy. These randomized, double-blind, placebo-controlled clinical trials are expected to include approximately 800 patients. The primary outcome measures of the trials are the Maintenance of Wakefulness Test (MWT) and the Clinical Global Impression of Change-Clinician (CGI-C). The trials are being conducted concurrently at sites in the United States, Europe, Canada and Australia.
The company remains on schedule to complete the OSA/HS program, and expects to file a New Drug Application (NDA) for R-modafinil with the U.S. Food and Drug Administration in the fourth quarter of 2004. In addition, the company will commence a study of R-modafinil in patients with Shift Work Sleep Disorder in early 2004 and intends to file a supplemental New Drug Application (sNDA) for that additional indication as well.
"The decision to move forward with this Phase III program was based on earlier placebo-controlled clinical trials that demonstrated that R-modafinil maintained wakefulness and had a longer duration of effect than does PROVIGIL," said Dr. Paul Blake, Senior Vice President, Clinical Research and Regulatory Affairs, at Cephalon.
Source: Cephalon, Inc.