Vanda Pharmaceuticals Inc announced results from the JET Study, a 3-night transatlantic travel study of the effects of tasimelteon on jet lag disorder. Tasimelteon was shown to be effective in treating jet lag disorder in travelers who flew from the United States to the United Kingdom.
“The results of the JET study are supportive and add to the body of evidence of the effects of tasimelteon on Jet Lag in the context of 5 and 8 hour time zone transatlantic travel,” says Mihael H. Polymeropoulos, MD, Vanda’s president and CEO, in a release.
The JET study was a two-phase transatlantic travel study, with an observational travel phase (baseline) followed by a treatment phase. Study participants traveled either 5 or 8 time zones from Washington DC to London and San Francisco or Los Angeles to London, respectively. They stayed in London for 3 nights and 4 days, and during randomization they received tasimelteon 20 mg for 3 consecutive nights prior to their bedtime. Efficacy was monitored by polysomnography (PSG) as well as sleep and wake questionnaire scales. Due to the complexity of the study, the study was terminated before it reached the original enrollment goal of 90 patients, with only 25 patients completing both phases of the study (tasimelteon n=13, placebo n=12).
Despite the small sample size (n=25) of this study, tasimelteon succeeded in demonstrating significant and meaningful effects across a number of sleep and wake measures.
Tasimelteon significantly improved total sleep time (TST) of the first 2/3 of the night on night 3, in both objective and subjective measures of sleep. Tasimelteon-treated patients slept 76 minutes longer during their second trip as compared to their first. Cumulatively over the 3 travel nights of their second trip, tasimelteon-treated patients added 131 minutes of sleep as compared to the 3 travel nights of the first trip.
Similar results favoring tasimelteon were seen in outcomes of the Post Sleep Questionnaire (PSQ), including subjective TST, subjective sleep latency, subjective wake after sleep onset, and subjective sleep quality. Measures of global function, including Patient Global Impression of Severity (PGI-S) and the Karolinska Sleepiness scale (KSS), also favored tasimelteon.
(The primary endpoint of the study was TST for the first 2/3 of the night(s) most likely to be disrupted. Examination of the observational phase baseline data demonstrated that night 3 was the night most disrupted with 197 minutes in TST 2/3, followed by night 1 and night 2 with 218 minutes and 250 minutes, respectively.)
Vanda intends to seek marketing approval for the use of HETLIOZ in the treatment of jet lag disorder. Vanda believes that if HETLIOZ is approved by regulatory authorities for the treatment of jet lag disorder, it will potentially offer a therapeutic solution to many travelers and may represent an important commercial opportunity for the company. Vanda plans to file a supplemental New Drug Application for the treatment of jet lag disorder with the FDA during the second half of 2018. HETLIOZ is not currently approved by any regulatory authority for the treatment of jet lag disorder.