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Published on 6/23/2006 in the Prospect News Biotech Daily.

Vanda: data from phase 2 trial shows effectiveness of VEC-162 in treatment of insomnia

By Lisa Kerner

Charlotte, N.C., June 23 - Vanda Pharmaceuticals Inc. said results from a phase 2 study demonstrated the effects of VEC-162 in a model of transient insomnia on the traditional measures of sleep onset and maintenance.

The randomized, double-blind study of 37 healthy subjects evaluated the efficacy of VEC-162 (10 mg, 20 mg, 50 mg and 100 mg), according to a company news release.

Patients' circadian rhythms were measured by plasma melatonin and time to persistent sleep was measured by polysomnography compared to a placebo.

There was a statistically significant shift in circadian rhythm at 50 mg and 100 mg of up to five hours in the first night.

All dosing arms experienced a reduction in the time it took to achieve persistent sleep, with sleep improvement of 23.4 minutes to 19.3 minutes depending on dose.

"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," chief executive officer Mihael Polymeropoulos said in the release.

The data were presented at the Sleep 20th Anniversary Meeting of the Associated Professional Sleep Societies.

Salt Lake City-based Vanda is a biopharmaceutical company that develops clinical-stage product candidates for central nervous system disorders.


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