Vanda's Hetlioz meets in Phase III for jet lag disorder
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) reported data from the double-blind, U.S. Phase III JET8 trial in 318 healthy volunteers undergoing a circadian challenge of an eight hour advance to their usual bedtime to induce jet lag disorder showing that 20 mg oral Hetlioz tasimelteon (VEC-162) met the primary endpoint of improving total sleep time in the first two thirds of the night vs. placebo (216.4 vs. 156.1 minutes, p<0.0001).
Hetlioz also met the secondary endpoints of improving full total sleep time (315.8 vs. 230.3 minutes, p<0.0001), Latency to Persistent Sleep (LPS) (21.8 vs. 36.8 minutes, p<0.01) and Wake After Sleep Onset (WASO) (144.6 vs. 219.1 minutes, p<0.0001) vs. placebo. Hetlioz also significantly improved next day alertness as measured by the Karolinska Sleepiness Scale (KSS) and a visual analog scale (VAS) vs. placebo (p<0.01 for both)...