|HETLIOZ® (tasimelteon) Effective in Treating Jet Lag during Transatlantic Travel|
"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," said
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
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, as summarized in Table 1.
Tasimelteon significantly improved total sleep time of the first 2/3 of the night (TST 2/3) 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 (TST 2/3) 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.
Table 1: Summary of Results
*The primary endpoint of the study was Total Sleep Time for the first 2/3 (TST 2/3)2 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. TST, Sleep Latency, and WASO shown in minutes.
The results of the JET study support the previously reported pivotal JET5 and JET8 Phase III studies, which demonstrated significant effects in circadian advances of 5 and 8 hours, respectively.1,2
Jet Lag Disorder affects millions of individuals annually who cross multiple time zones during their travel. Jet Lag Disorder symptoms are more severe during eastward travel. It is reported that more than 30 million US residents make trips abroad each year to overseas destinations. Of these, 60% (approximately 20 million) travel to destinations in
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
HETLIOZ® IS NOT CURRENTLY APPROVED BY ANY REGULATORY AUTHORITY FOR THE TREATMENT OF JET LAG DISORDER.
HETLIOZ® is a melatonin receptor agonist. HETLIOZ® has been granted market authorization by the
Important Safety Information
The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.
HETLIOZ® is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).
Important Safety Information
HETLIOZ® may cause somnolence: After taking HETLIOZ®, patients should limit their activity to preparing for going to bed, because HETLIOZ® can potentially impair the performance of activities requiring complete mental alertness.
The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.
Use of HETLIOZ® should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ®, and a greater risk of adverse reactions. HETLIOZ® should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ®, with reduced efficacy.
There are no adequate and well-controlled studies of HETLIOZ® in pregnant women. Based on animal data, HETLIOZ® may cause fetal harm. HETLIOZ® should be used during pregnancy only if the potential benefit justifies the potential risks. Caution should be exercised when HETLIOZ® is administered to a nursing woman.
HETLIOZ® has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
Safety and effectiveness of HETLIOZ® in pediatric patients have not been established.
Vanda is a global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on
1. Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman E. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomized controlled multicenter trials. The Lancet. 2009: 373: 433-516.
2. HETLIOZ® (tasimelteon) Demonstrates Efficacy to Treat Jet Lag Disorder in an 8 Hour Phase Advance Clinical Study. https://www.prnewswire.com/news-releases/hetlioz-tasimelteon-demonstrates-efficacy-to-treat-jet-lag-disorder-in-an-8-hour-phase-advance-clinical-study-300607853.html
FORWARD LOOKING STATEMENTS
Various statements in this release are "forward-looking statements" under the securities laws. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others: the ability of HETIOZ® to provide significant benefit in the treatment of the symptoms of Jet Lag Disorder; Vanda's ability to obtain marketing approval for the use of HETLIOZ® in the treatment of Jet Lag Disorder; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's annual report on Form 10-K for the fiscal year ended
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.