Somnus compound meets Phase II insomnia endpoint

Somnus Therapeutics Inc. (Bedminster, N.J.) said all three 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 two vs. placebo in a Phase II trial to prevent middle of the night awakening. The double-blind, crossover, U.S. trial enrolled 67 patients with primary insomnia characterized by middle of the night awakening. Data were presented at the joint meeting of the American Academy of Sleep Medicine and the Sleep Research Society in Minneapolis. Somnus said it plans to hold an end-of-Phase II meeting with FDA next month. ...