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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

mean TST during the first third of the night improved by 45.2 minutes in the 20mg group (p<.001), by 40.1 minutes in the 50mg group (p<.01), and by 30.6 minutes in the placebo group. All statistical comparisons are between tasimelteon dose versus placebo.

-- Mean WASO during the first third of the night at baseline (before drug treatment) was 20.8 minutes in the 20mg group, 21.3 minutes in the 50mg group, and 21.3 minutes in the placebo group. On Nights 1 and 8 of treatment, mean WASO during the first third of the night improved by 2.3 minutes in the 20mg group (p<.01), and by 1.8 minutes in the 50mg group (p<.05), but worsened by 3.1 minutes in the placebo group. On Nights 22 and 29 of treatment, mean WASO during the first third of the night improved by 3.1 minutes in the 20mg group (nss), by 1.8 minutes in the 50mg group (nss) and by 0.6 minutes in the placebo group. All statistical comparisons are between tasimelteon dose versus placebo.

These results reveal that tasimelteon was able to achieve a number of statistically significant improvements on sleep maintenance parameters during the portion of the night in which the patient population studied suffered the greatest impairment. These data are consistent with data from the prior Phase III study (VP-VEC-162-3101), in which 20mg and 50mg of tasimelteon significantly improved LPS (by 21.5 to 26.3 minutes compared to placebo), WASO (by 24.7 to 33.7 minutes compared to placebo), and TST (by 33.7 to 47.9 minutes compared to placebo) in a model of transient insomnia. Taken together, the results of both of these studies demonstrate the versatility of tasimelteon to treat the symptoms of insomnia acutely and chronically both in a model of transient insomnia and in patients with chronic primary insomnia.

"These results suggest that circadian misalignment may play an important role in the pathophysiology of chronic primary insomnia in many patients, especially those who have difficulty falling asleep,"
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SOURCE Vanda Pharmaceuticals Inc.
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