Buy Provigil Online

The NDA is based on positive results of four double-blind, randomized, placebo-controlled studies of NUVIGIL in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSA/HS. The data in this filing show that the primary endpoints of all studies were met and suggest that NUVIGIL is differentiated from PROVIGIL.

“This is the third of five FDA approvals that we will be pursuing over a 15-month time period,” said Dr. Paul Blake, Executive Vice President, Worldwide Clinical Research & Regulatory Affairs at Cephalon. “Cephalon is a pioneer in developing compounds for improving wakefulness, and this on- schedule filing allows us to reinforce our leadership position in the treatment of disorders of sleep and wakefulness,” added Dr. Blake.

Provigil appears to be unlike classic stimulants. We investigated this generality by testing the selectivity of this compound for wake-promoting effects (e.g., relative to locomotor effects) and homeostatic sleep responses after drug-induced waking relative to the prototypical stimulant methamphetamine (METH).

Continuous measures of electroencephalogram (EEG) sleep-wakefulness, locomotor activity (LMA) and body temperature (Tb) were obtained from adult male Wistar rats 3 days before and after treatment with Provigil (30, 100 and 300 mg/kg i.p.), 0.25% methylcellulose (vehicle) or METH (0.5 and 1.0 mg/kg i.p.). Individually housed rats in a 24-h light-dark cycle (LD 12:12) were treated 5 h after lights-on (CT-5).

LMA and Tb were monitored via intraperitoneal telemetry. Sleep-wake stages and LMA were recorded every 10 s, Tb every minute. During the first 3 h post-treatment, Provigil and METH significantly and dose-dependently increased EEG wake time (P < .01 for 30 mg/kg Provigil, all other P < .0001) and wake episode duration.

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Efficacy was assessed using the Maintenance of Wakefulness Test (MWT) (six 20-min subtests across the day), the Clinical Global Impression of Change (CGI-C), subjective measures of sleepiness (Epworth Sleepiness Scale), patient diaries, and evaluations of cognitive performance (Cognitive Drug Research) and fatigue (Brief Fatigue Inventory).

Provigil significantly increased MWT mean sleep latency (at 0900-1500) compared with placebo. The mean change from baseline at final visit for Provigil was an increase of 1.3, 2.6, and 1.9 min in the 150-mg, 250-mg, and combined groups, respectively, compared with a decrease of 1.9 min for placebo (p < 0.01 for all three comparisons).

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