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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

y if symptoms of insomnia were chronic and LPS was greater than 30 minutes.

Significant Improvement in Sleep Onset Sustained through Study Duration

These results demonstrate that tasimelteon was able to improve LPS significantly, and that this effect persisted for the 4 week duration of the study. The results on LPS at night 1 (N1)/night 8 (N8), and night 22 (N22)/night 29 (N29) are as follows.

-- Mean LPS at baseline (before drug treatment) was 78.8 minutes in the 20mg group, 76.4 minutes in the 50mg group, and 78.2 minutes in the placebo group. On Nights 1 and 8 of treatment, mean LPS improved by 45.0 minutes in the 20mg group (p<.001), by 46.4 minutes in the 50mg group (p<.001), and by 28.3 minutes in the placebo group. On Nights 22 and 29 of treatment, mean LPS improved by 49.4 minutes in the 20mg group (p<.001), by 45.1 minutes in the 50mg group (p=.016), and by 33.9 minutes in the placebo group. All statistical comparisons are between tasimelteon dose versus placebo.

Importantly, this effect was also seen acutely on the first night of treatment. Patients in the 20mg and 50mg groups fell asleep 22.9 minutes (p<.001) and 25.9 minutes (p<.001) faster, respectively, than those in the

placebo group, as measured objectively through PSG. Data from subjective patient self-reports on these nights were consistent with this finding.

Additional Phase III Results on Sleep Maintenance Parameters

The trial also evaluated parameters of sleep maintenance, including TST and WASO.

-- Mean TST at baseline (before drug treatment) was 325.7 minutes in the 20mg group, 327.0 minutes in the 50mg group, and 328.9 minutes in the placebo group. On Nights 1 and 8 of treatment, mean TST improved by 51.4 minutes in the 20mg group (p=.089), by 52.0 minutes in the 50mg group (p=.074), and by 40.0 minutes in the placebo group. On Nights 22 and 29 of treatment, mean TST improved by 60.3 minutes in the 20mg group (p=.057), by 48.6 minutes i
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SOURCE Vanda Pharmaceuticals Inc.
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