VANDA REPORTS POSITIVE RESULTS FROM INSOMNIA STUDY

Vanda Pharmaceuticals has announced positive top-line results from the company's Phase III clinical trial evaluating VEC-162, a balanced melatonin receptor agonist, in transient insomnia.

VEC-162 demonstrated statistically significant improvements at all three tested doses compared with placebo in the primary endpoint of the trial, latency to persistent sleep, a measure of sleep onset. VEC-162 also produced statistically significant improvements relative to placebo in latency to non-awake, another measure of sleep onset, wake after sleep onset, a measure of sleep maintenance, and total sleep time. VEC-162 was also shown to be safe and well-tolerated.

The Phase III trial was a randomized, double-blind, placebo-controlled, multicenter study that enrolled 412 adults in a sleep laboratory setting using a phase-advance, first-night assessment model of induced transient insomnia. The trial examined VEC-162 dosed 30 minutes before bedtime at 20, 50 and 100 mg versus placebo.

"This study demonstrates VEC-162's ability to induce and maintain sleep," Paolo Baroldi, senior vice president of Vanda, said. "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."