A randomized, double-blind study of 37 healthy subjects was conducted to evaluate the efficacy of VEC-162 (10, 20, 50 and 100mg) in a model of transient insomnia. The primary objectives of the study were to evaluate the efficacy of VEC-162 in shifting patients’ circadian rhythm as measured by plasma melatonin and in improving time to persistent sleep as measured by polysomnography (PSG) when compared with placebo in a model of transient insomnia. Secondary objectives included wakefulness after sleep onset (WASO), safety and tolerability.
On circadian rhythm, there was a statistically significant shift in circadian rhythm at 50 and 100mg of up to five hours in the first night, and a statistically significant dose-response curve. On polysomnographic measures of sleep efficacy, all dosing arms experienced a reduction in time it took to achieve persistent sleep.
“We are encouraged by these clinical results which demonstrate that, in VEC-162, we may have the first therapy available to treat the millions of patients who suffer from the consequences of a misalignment of their sleep/wake cycle,” said Dr Mihael Polymeropoulos, CEO of Vanda.
The data were presented at the SLEEP 20th anniversary meeting of the Associated Professional Sleep Societies (APSS) by Dr Shantha Rajaratnam, of the division of sleep medicine at Brigham and Women’s Hospital, Harvard Medical School.