Vanda Pharmaceuticals asserted that HETLIOZ which is a circadian regulator exhibited significant and clinically meaningful benefits in symptoms of jet lag disorder.
Jet lag disorder is a common circadian disorder frequently observed in millions of travelers who cross multiple time zones. Jet lag disorder is characterized by nighttime sleep disruption, a decrease in daytime alertness and impairment to social and occupational functioning.
The clinical efficacy results reported today are from the JET8 Phase-III clinical study (3107) (the JET8 study). In the JET8 study, 318 healthy volunteers were admitted to a sleep unit and were subjected to a circadian challenge of an 8 hours advance to their usual bedtime. The JET8 study design induced the circadian challenge experienced by travelers who cross 8 times zones, which leads to jet lag disorder. This clinical design allowed for the study of HETLIOZ.
Results from the JET8 study exhibited remarkable and clinically meaningful effects of HETLIOZ® 20 mg on the primary endpoint of the study as well as multiple secondary endpoints. The pre-specified primary endpoint was the amount of sleep time in the first two thirds of the night. Secondary endpoints included measures of sleep parameters.
Mihael H. Polymeropoulos, MD, Vanda’s President and CEO said ” We are extremely pleased with the outcome of this study which establishes the utility of HETLIOZ in the treatment of jet lag disorder as HETLIOZwas shown to overcome a significant circadian challenge of an 8 hour phase advance. This challenge is equivalent to eastward travel across 8 time zones as experienced for example on travel from Los Angeles to London, Washington DC to Moscow, Paris to Tokyo, or London to Singapore. HETLIOZ improved both nighttime sleep and next day alertness potentially offering significant benefits to millions of travelers,”
The results of the JET8 study shown above demonstrate the effectiveness of HETLIOZ in treating jet lag disorder. The magnitude of the total sleep time benefit of 85 minutes improvement over placebo is significant and clinically meaningful.