| Information |
Generic Name: |
tasimelteon
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| Trade Name: |
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| Entry Type: |
Licence extension |
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| Developmental Status |
| UK: |
None |
| EU: |
None |
| US: |
Phase III Clinical Trials |
| UK launch Plans: |
Available only to registered users |
| Actual UK launch date: |
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| Comments |
Dec 12: Vanda plans to file in the US in mid-2013 [5].
18/12/2012 22:04:55 |
Mar 11: Tasimelteon granted orphan drug status in the EU for Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals with no light perception [2].
10/03/2011 10:34:28 |
Aug 10: PIII study started [1]
01/09/2010 10:08:10 |
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| Trial or other data |
Jan 13: Vanda announces positive PIII RESET results. The primary endpoint of the study was the maintenance of effect as measured by entrainment of the melatonin (aMT6s) rhythm - these occurred in 90% in the tasimelteon gp vs. 20% in the placebo gp (p=0.0026). Results for the secondary endpoints in the tasimelteon vs. placebo groups were maintenance of entrainment of the cortisol rhythm 80% vs. 20% (p=0.0118), LQ-nTST (total nighttime sleep in the worst 25% of nights; LS mean minutes) -6.6 vs. -73.8 (p=0.0233), UQ-dTSD (total daytime sleep duration in the worst 25% of days; LS mean minutes) -9.6 vs. 49.8 (p=0.0266) & MoST (midpoint of sleep timing from both nighttime and daytime sleep; LS mean minutes) 19.8 vs. -16.2 (p=0.0108) [6].
24/01/2013 11:12:01 |
Dec 12: Results from the PIII SETS trial reported. In the randomized, double-masked study in 84 patients with Non-24, the primary endpoint of entrainment of the melatonin (aMT6s) rhythm was achieved vs placebo. Tasimelteon demonstrated significant improvements across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep. Improvements in the Non-24 Clinical Response Scale (N24CRS) and the Clinical Global Impression of Change (CGI-C) were also noted.Tasimelteon was found to be safe and well tolerated. Vanda expects to report top-line results from the second RESET in Q1 2013 [5].
18/12/2012 22:13:17 |
Oct 12: In an open-label segment of the PIII RESET study totally blind patients with Non-24 were given a 20mg tasimelteon daily at bedtime for 6 weeks. The rhythms of melatonin and cortisol were assessed longitudinally in urine samples. The study found that entrainment of cortisol rhythm by tasimelteon was directly associated with entrainment of the melatonin rhythm. Vanda believes that the simultaneous entrainment of melatonin and cortisol suggests that tasimelteon can reset the master body clock in the suprachiasmatic nucleus (SCN) through binding to MT1 and MT2 melatonin receptors [4].
16/10/2012 11:36:26 |
Jan 12: Vanda is currently studying the efficacy of tasimelteon in Non-24-Hour Disorder in two PIII studies, SET and RESET, which are due to be completed by the end of 2012. RESET (NCT01430754) is a randomized withdrawal study designed to demonstrate the maintenance effect of 20mg tasimelteon. 20 totally blind individuals with no light perception and diagnosed as having a body clock period of greater than 24 hours, will be treated with tasimelteon for 3 months during a run-in phase. Patients who respond to treatment during the run-in phase, will be randomized either to receive placebo or to continue receiving tasimelteon for 2 months. Based on observations from 4 patients the company has reported that tasimelteon has been shown for the first time to reset the body clock and to align it to a constant 24-hour day [3].
27/01/2012 08:35:28 |
Aug 10: a PIII trial (VP-VEC-162-3201) to evaluate tasimelteon 20mg vs placebo in 160 patients with Non-24-Hour Sleep Wake Disorder (N24HSWD), a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness has started. The study includes a 6-month treatment period and an optional open-label extension. The primary endpoint is improvement in Total Sleep Time (TST) during the night. The study will also measure parameters of daytime sleep and laboratory measures of the synchronization between the internal body clock and the 24-hour environmental light/dark cycle. Top-line results are expected 4Q 2011 [1].
01/09/2010 10:10:08 |
The goal of treatment is to synchronize circadian rhythms into an appropriate phase relationship with the 24-hour day with increased sleepiness during the night and increased wakefulness during the day [1].
01/09/2010 10:09:59 |
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| References |
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| Available only to registered users |
Uk Medicines Information 