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Vanda Pharmaceuticals' VSF-173 Excessive Sleepiness Phase II Clinical Trial Suggests Wake-Promoting Properties
Date:10/30/2007

ROCKVILLE, Md., Oct. 30 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, today announced top-line results from the Company's Proof- of-Concept Phase II clinical trial evaluating VSF-173 in a clinical model of excessive sleepiness.

This Phase II study examined the effects of VSF-173 on a model of excessive sleepiness among 55 healthy volunteers treated with 3 doses of VSF-173 administered at 50 mg, 100 mg and 200 mg and placebo administered at 25 mg, 50 mg and 100 mg at the usual bedtime and at four hours after the first dose. In this model, the effect of the compound was evaluated with a series of six Maintenance of Wakefulness Tests (MWT) given two hours apart starting one hour after the first dose. The effect of the drug was also evaluated on the scheduled daytime recovery sleep following the night time and morning evaluations.

On the primary endpoint which evaluated the effect of the compound on the first four series of MWT tests, VSF-173 demonstrated improvements over placebo. The mean MWT sleep onset scores for the 50 mg, 100 mg and 200 mg, and placebo groups were 10.3, 12.9, 10.6 and 9.2 minutes, respectively. While the pair-wise analysis did not reach statistical significance, this magnitude of effect, ranging from 1.1 to 3.7 minutes, is generally similar to that observed with modafinil in the treatment of patients with narcolepsy.

In a subset of 37 subjects with no observed impairment in pre-dose daytime wakefulness (MWT cutoff equal to 30 minutes), the mean of all six MWT scores for the 50 mg, 100 mg and 200 mg groups show
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SOURCE Vanda Pharmaceuticals Inc.
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