The time difference is not bad! New drugs can effectively increase sleep time
May 25, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Vanda Pharmaceuticals, a Washington-based biotechnology company, recently announced the results of a phase 2 clinical study called JET. The study evaluated the efficacy of the drug tasimelteon (HETLIOZ®) in a transatlantic population. The results show that tasimelteon can effectively improve the Jet Lag Disorder of travelers from the United States to the United Kingdom.
Traveling across time zones can disturb people's biological rhythms, making people feel weak during the day due to jet lag, and it is difficult to sleep at night. Such a state is neither good for work nor good for health. The jet lag affects millions of passengers each year, and the time difference of travellers traveling east is more serious. According to reports, more than 30 million American residents travel abroad to overseas destinations every year. Among them, 60% (about 20 million) travel to destinations in Europe, the Middle East and Asia. A large number of these passengers are plagued by jet lag, and if drugs can help them solve sleep problems, it will lead to an improvement in quality of life.
Tasimelteon is a melatonin receptor agonist. In the human body, melatonin activates its receptors to produce a sleep aid effect, and tasimelteon also helps people sleep with a similar mechanism. In 2014, it was approved by the US FDA to treat “Non-24-hour sleep-wake disorderâ€, which is also a disorder in which sleep cycles occur.
The JET study is a two-stage transatlantic travel study that includes the observation phase (baseline) and the treatment phase. Participants will cross five or eight time zones, starting in Washington, DC or San Francisco/Los Angeles, with a destination in London. Participants stayed in London for 4 days and 3 nights. They were randomized to receive 20 mg of tasimelteon for 3 consecutive nights before going to bed. The efficacy was assessed using the Polysomnography (PSG) and Sleep Awakening Questionnaire. Due to the complexity of the study, a total of 25 patients completed the two phases of the study (tasimelteon n=13, placebo n=12).
The primary endpoint of the study was the first 2/3 of total sleep time (TST) (TST 2/3), which is the period of time when sleep is most likely to be interrupted. Baseline data from the observation phase indicated that these passengers had the most interruptions in sleep on the third night, with TST 2/3 being only 197 minutes, and on the first night and the second night being 218 minutes and 250 minutes, respectively.
â–²Vanda Pharmaceuticals' product line (Source: Vanda Pharmaceuticals official website)
The results showed that tasimelteon significantly improved TST 2/3 on the third night in subjective and objectively measured sleep quality. Patients receiving treatment with tasimelteon had a 76-minute TST 2/3 on the third night of the second trip compared to baseline. During the three nights of the trip, patients treated with tasimelteon increased a total of 131 minutes of sleep time of TST 2/3.
Post-sleep questionnaires (PSQ) included subjective TST, sleep latency, subjective sleep waking time, and subjective sleep quality. The survey results showed that taking tasimelteon was beneficial to passengers' sleep. Other overall measurements, including patient overall impression severity (PGI-S) and the Karolinska Sleepiness Scale (KSS), also showed the benefits of tasimelteon.
The results of the JET study support the previously reported key phase 3 clinical studies of JET5 and JET8, which have shown significant modulation of tasimelteon on 5 and 8 hour circadian progression. Therefore, Dr. Mihael H. Polymeropoulos, President and CEO of Vanda, said: “The results of the JET study were supportive and enhanced the evidence for the effect of tasimelteon on improving jet lag within the 5-hour and 8-hour transatlantic travel. â€
Reference materials:
[1] HETLIOZ® (tasimelteon) Effective in Treating Jet Lag during Transatlantic Travel
[2] Vanda Pharmaceuticals official website
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