VEC-162 demonstrated statistically significant improvements at all three tested doses compared to placebo in the primary endpoint of the trial, sleep onset. VEC-162 was also demonstrated to be safe and well-tolerated.
“This study demonstrates VEC-162's ability to induce and maintain sleep. Also because VEC-162 is a balanced melatonin receptor agonist that works through the natural sleep/wake cycle, it appears to lack the side effects associated with hypnotics and sedatives and should not be scheduled as a controlled substance,” stated Paolo Baroldi, senior vice president of Vanda.
Vanda commented that VEC-162 may be an effective new treatment for patients with circadian rhythm sleep disorders for whom there is currently no available drug treatment. CRSDs are sleep disorders arising from a misalignment of the circadian rhythm, where a person's internal sleep/wake cycle does not match his or her desired sleep time. Examples include shift worker sleep disorder, delayed sleep phase syndrome, and jet lag. The company believes VEC-162 is the only compound with a proven ability to modify the sleep/wake cycle.