Good Ph III results with Vanda insomnia drug

Vanda Pharmaceuticals has reported positive top-line results from a Phase III clinical trial evaluating VEC-162, its balanced melatonin receptor agonist, in transient insomnia. According to the USA-based drugmaker, the agent demonstrated statistically-significant improvements at all three tested doses compared to placebo (p<0.001) 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, waking after sleep, a measure of sleep maintenance and total sleep time. On the day of the news, November 15, shares in the Rockville, Maryland-based company soared 25.5% to $12.25.

The Phase III randomized, double-blind, 412-patient, placebo-controlled, multicenter study used a phase-advance, first-night assessment model of induced transient insomnia. VEC-162 was dosed 30 minutes before bedtime at 20mg, 50mg and 100mg versus placebo. The drug achieved statistically-significant results in multiple endpoints captured using polysomnography, including: LPS improvements of 21.5 minutes (p<0.001), 26.3 minutes (p<0.001), and 22.8 minutes (p<0.001), according to all three dosages, respectively. LNA improvement compared with placebo of 11.1 minutes (p<0.006), 14.3 minutes (p<0.001), and 12.3 minutes (p<0.002), respectively.