SKP-1041: Phase II data

A double-blind, crossover, U.S. Phase II trial in 67 patients with primary insomnia characterized by middle of the night awakening showed that 10, 15 and 20 mg doses of oral SKP-1041 given before bedtime each met the primary endpoint of significantly reducing wake time after sleep onset from baseline to day 2 vs. placebo (p=0.01, p=0.004 and p=0.008, respectively). Additionally, all 3 doses of SKP-1041 met the secondary endpoint of significantly increasing total sleep time between hours 3-7 of an 8-hour sleep period vs. placebo (p=0.009, p=0.002 and p=0.003, respectively). Mid- and high-dose SKP-1041 also met the secondary endpoint of significantly reducing the number of middle-of-the-night awakenings during hours 3-7 vs. placebo (p=0.003 and p=0.022, respectively), but low-dose SKP-1041 missed the endpoint. ...