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Phase III Data Show Vanda Pharmaceuticals' Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia
Date:6/26/2008

n the 50mg group (not statistically significant, nss), and by 47.4 minutes in the placebo group. All statistical comparisons are between tasimelteon dose versus placebo.

-- Mean WASO at baseline (before drug treatment) was 92.6 minutes in the 20mg group, 93.8 minutes in the 50mg group, and 93.8 minutes in the placebo group. On Nights 1 and 8 of treatment, mean WASO improved by 12.2 minutes in the 20mg group (nss), by 14.1 minutes in the 50mg group (nss), and by 11.7 minutes in the placebo group. On Nights 22 and 29 of treatment, mean WASO improved by 17.7 minutes in the 20mg group (nss), by 10.2 minutes in the 50mg group (nss), and by 20.3 minutes in the placebo group. There were no significant differences in this secondary endpoint comparing tasimelteon versus placebo groups.

Analysis of the baseline PSG data revealed that the sleep disruption in this patient population occurred primarily during the first third of the 8-hour night. This is not unexpected given that the entry criteria in the study focused upon recruiting subjects with difficulty falling asleep and that there was no WASO entry criterion. At baseline, sleep efficiency (i.e. the percent of time spent asleep during the time available for sleep) during the first, second and last thirds of the night were 50.7%, 79.4% and 74.5%, respectively. Therefore, Vanda evaluated the effect of tasimelteon on sleep maintenance parameters in the first third of the night, when the sleep disruption was greatest in this population of chronic primary insomnia patients.

-- Mean TST during the first third of the night at baseline (before drug treatment) was 79.0 minutes in the 20mg group, 82.3 minutes in the 50mg group, and 82.2 minutes in the placebo group. On Nights 1 and 8 of treatment, mean TST during the first third of the night improved by 40.9 minutes in the 20mg group (p<.001), by 39.4 minutes in the 50mg group (p<.001), and by 26.6 minutes in the placebo group. On Nights 22 and 29 of treatment,
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SOURCE Vanda Pharmaceuticals Inc.
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