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This novel phase three, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of Nuvigil (50 or 150mg/day) in 427 healthy men and women aged 18 to 65 over the course of three days. Study participants all had experienced jet lag symptoms at least once during the previous five years.
Participants in the study traveled eastbound from the US to France, where they were then evaluated at a sleep facility. Clinical efficacy in the study was demonstrated using two measures: an objective assessment (Multiple Sleep Latency Test, MSLT), and a subjective assessment (Patient Global Impression of Severity, PGI-S).
According to Cephalon, the data showed Nuvigil significantly improved wakefulness in the participants, as assessed by the MSLT averaged across days one and two. Participants taking Nuvigil 150mg/day had an average time to fall asleep of 11.7 minutes, compared to 4.8 minutes for subjects taking placebo and 7.7 minutes for subjects taking Nuvigil 50mg/day (p<0.0001 for both doses compared with placebo). An average time to fall asleep of less than 5 minutes on the MSLT is considered pathological sleepiness and an average time to fall asleep of greater than 10 minutes is considered within the normal range.
Researchers also found that Nuvigil 150mg/day significantly improved patient-reported clinical condition, as assessed by the mean PGI-S [rating 1=normal to 7=extremely ill], averaged across days one and two, compared with placebo (1.6 armodafinil 150mg/day versus 1.9 placebo; p=0.04). Nuvigil was generally well-tolerated in the study, the company said.
Nuvigil is currently indicated to improve wakefulness throughout the day for the millions of patients who struggle with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder and narcolepsy.
Lesley Russell, chief medical officer and executive vice president at Cephalon, said: "Based on the findings of this study, Cephalon will submit a supplemental new drug application to the FDA during the third quarter of 2009."
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