FRAZER, Pa., May 6, 2011 /PRNewswire/ -- At the Society of
General Internal Medicine's 34th Annual Meeting in Phoenix, Ariz. today, Cephalon, Inc. (Nasdaq:
CEPH) presented positive results from a phase IV trial of nearly
400 people with excessive sleepiness associated with shift work
disorder. In the trial, NUVIGIL® (armodafinil) Tablets [C-IV]
improved shift-workers' overall clinical condition late in their
shifts (i.e., 4:00 a.m. to 8:00
a.m.), including the commute home, compared to placebo. The
key secondary endpoint of the study was to assess global function,
as measured by the Global Assessment of Functioning (GAF), and
patients taking NUVIGIL experienced a greater improvement in GAF
score compared to those patients taking placebo. Shift work
disorder occurs when the body's internal sleep-wake clock is out of
sync with the individual's work schedule – their bodies tell them
to go to sleep when their work schedule needs them to stay awake.
The primary symptoms of shift work disorder are excessive
sleepiness and insomnia.
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This six-week, double-blind, placebo-controlled study of 383
patients with excessive sleepiness associated with shift work
disorder was conducted at 45 sites across the United States. Participants in the
study spanned a wide range of occupations associated with shifts or
non-traditional work hours, including transportation and material
moving, healthcare support, protective services, management roles
and office and administrative support. For the primary
endpoint, physicians used the Clinical Global Impression of Change
(CGI-C) scale to evaluate the change from baseline (beginning of
the study) in overall clinical condition late in the shift – from
4:00 a.m. to 8:00 a.m. The
observation period also included the participant's commute home
from work. Using the CGI-C rating, at the final visit, 77
percent of patients taking the recommended NUVIGIL dose of 150 mg
(n=177) improved, compared to 57 percent of patients taking placebo
(n=182) – a significantly greater improvement (p