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"We are excited that the results of this Phase III chronic insomnia studydemonstrate the clinical utility of tasimelteon and the ability of thecompound to treat sleep disorders over a period of four weeks. The mechanismof action of tasimelteon as a circadian regulator gives Vanda the opportunityto explore its use for the treatment of circadian rhythm sleep disorders aswell as chronic primary insomnia," stated Paolo Baroldi, MD, PhD, Vanda'sChief Medical Officer.
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This Phase III, multi-center, placebo-controlled, 4-week trial evaluated322 patients with chronic primary insomnia. Patients were randomized toreceive either 20 mg or 50 mg of tasimelteon or placebo over the course offour weeks. The primary endpoint consisted of the evaluation of the immediateand short-term (average of Nights 1 and 8) ability of tasimelteon to improvesleep onset as measured by Latency to Persistent Sleep (LPS) throughpolysomnography (PSG). Secondary endpoints evaluated tasimelteon's ability tomaintain improvements on sleep onset after long-term (average of Nights 22 and29) use of the compound as well as measures of sleep duration (Total SleepTime, TST) and sleep maintenance (Wake After Sleep Onset, WASO). Patients wereeligible for the study if symptoms of insomnia were chronic and LPS wasgreater than 30 minutes.
Significant Improvement in Sleep Onset Sustained through Study Duration
These results demonstrate that tasimelteon was able to improve LPSsignificantly, and that this effect persisted for the 4 week duration of thestudy. 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 the20mg group, 76.4 minutes in the 50mg group, and 78.2 minutes in the placebogroup. On Nights 1 and 8 of treatment, mean LPS improved by 45.0 minutes inthe 20mg group (p<.001), by 46.4 minutes in the 50mg group (p<.001), and by28.3 minutes in the placebo group. On Nights 22 and 29 of treatment, mean LPSimproved by 49.4 minutes in the 20mg group (p<.001), by 45.1 minutes in the50mg group (p=.016), and by 33.9 minutes in the placebo group. All statisticalcomparisons are between tasimelteon dose versus placebo.
Importantly, this effect was also seen acutely on the first night oftreatment. 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 subjectivepatient 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 TSTand WASO.
-- Mean TST at baseline (before drug treatment) was 325.7 minutes in the20mg group, 327.0 minutes in the 50mg group, and 328.9 minutes in the placebogroup. On Nights 1 and 8 of treatment, mean TST improved by 51.4 minutes inthe 20mg group (p=.089), by 52.0 minutes in the 50mg group (p=.074), and by40.0 minutes in the placebo group. On Nights 22 and 29 of treatment, mean TSTimproved by 60.3 minutes in the 20mg group (p=.057), by 48.6 minutes in the50mg group (not statistically significant, nss), and by 47.4 minutes in theplacebo group. All statistical comparisons are between tasimelteon dose versusplacebo.
-- Mean WASO at baseline (before drug treatment) was 92.6 minutes in the20mg group, 93.8 minutes in the 50mg group, and 93.8 minutes in the placebogroup. On Nights 1
