Monday, May 9, 2011

Cephalon presents positive phase IV results with Nuvigil in largest shift work disorder trial

Cephalon, Inc. announced that it had presented positive results from a phase IV trial of nearly 400 people with excessive sleepiness associated with shift work disorder at the Society of General Internal Medicine's 34th Annual Meeting in Phoenix, Arizona. 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.

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<0.0001). These clinical data build upon the findings from the pivotal phase III study of Nuvigil in patients with excessive sleepiness associated with shift work disorder.

The key secondary endpoint in this trial was the Global Assessment of Functioning or GAF, a well-recognized assessment of patient functioning found in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, which evaluates an individual's social, occupational, and psychological functioning on a scale of 1 to 100. Scores above 70 on the Global Assessment of Functioning may be considered within the normal range of functioning. This study was the first to use the GAF to provide an assessment of functioning in patients with excessive sleepiness associated with shift work disorder. In this trial, physicians used the GAF to measure a patient's overall level of functioning at baseline and at the final visit. At baseline, patients in both the placebo and Nuvigil groups were rated an average score of 63, which is indicative of functional impairment associated with shift work disorder. Patients treated with Nuvigil experienced a 9.5 point improvement over baseline in the Global Assessment of Functioning, to mean scores of 72.6 at the final visit, compared to a 5.2 point improvement to means scores of 67.9 in those taking placebo at final visit (p< 0.0001).

"This study is important because up to 25 percent of people who work nights, early mornings, or other nontraditional shifts may be affected by shift work disorder. This condition affects their ability to function at work and at home, but they still need to do their jobs. The results of this study show an improvement in condition as well as a reduction in the impairment of patients treated with Nuvigil for excessive sleepiness associated with shift work disorder when compared to placebo," said Milton K. Erman, M.D., study lead investigator. Dr. Erman is a Clinical Professor of Psychiatry at the University of California San Diego and President, Pacific Sleep Medicine Services, San Diego, CA. "This study reinforces the need for healthcare professionals to learn more about this disorder and about how treatment options like Nuvigil may be of help in managing excessive sleepiness due to shift work disorder."

The most frequently reported adverse events in this study are similar to those described in the Nuvigil prescribing information, and include headache, nausea, and insomnia. There were no serious adverse events observed in patients taking Nuvigil in this study. This is the first presentation of these data at a medical meeting and additional results will be submitted for future publications and presentations.

According to the US Department of Labor, over 15 million Americans work odd hours or non-traditional shifts, and are "at risk" for shift work disorder. Approximately 10 - 25 percent of shift workers are estimated to have shift work disorder. People with shift work disorder often struggle to stay awake during their waking hours (excessive sleepiness), or have trouble sleeping during their sleeping hours (insomnia).

Nuvigil is indicated to improve wakefulness in patients with excessive sleepiness associated with shift work disorder (SWD), treated obstructive sleep apnea (OSA), or narcolepsy. In patients with OSA, Nuvigil is used along with other medical treatments for this condition. The Nuvigil (armodafinil) label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment, that has been reported in adults in association with the use of modafinil and armodafinil and in children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in Nuvigil). Nuvigil is not approved for use in pediatric patients for any indication.

The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness, and insomnia.

Cephalon is a global biopharmaceutical company dedicated to discovering, developing and bringing to market medications to improve the quality of life of individuals around the world. Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients in several therapeutic areas.

Source: Pharmabiz


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