"Vanda Pharmaceuticals Inc. Vanda NASDAQ VNDA httpstudio.financialcontent.comprnewsPageQuoteTickerVNDA today announced that HETLIOZ a circadian regulator demonstrated significant and clinically meaningful benefits in nighttime and daytime symptoms of jet lag disorder.  HETLIOZ is currently approved in the US and Europe for the treatment of Nonhour sleepwake disorder a rare and chronic circadian rhythm sleep 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 JET PhaseIII clinical study  the JET study. In the JET study  healthy volunteers were admitted to a sleep unit and were subjected to a circadian challenge of an  hours advance to their usual bedtime. The JET study design induced the circadian challenge experienced by travelers who cross  times zones which leads to jet lag disorder.  This clinical design allowed for the study of HETLIOZ without the confounding effects of sleep deprivation and variable light conditions. Results from the JET study showed significant and clinically meaningful effects of HETLIOZ  mg on the primary endpoint of the study as well as multiple secondary endpoints. The prespecified primary endpoint was the amount of sleep time in the first two thirds of the night. Secondary endpoints included measures of sleep parameters TST LPS WASO and next day alertness KSS and VAS. Table .  Table  Summary of Primary and Key Secondary Endpoint Results Assessment Endpoint HETLIOZ Placebo Difference pvalue Summary pvalue Detail   PSG TST . . . p. .E   minutes TSTfull . . . p. .E    LPS . . . p. .E    WASO . . . p. .E            KSS  average . . . p. .E   VAS  average . . . p. .E   Primary endpoint. The results of the JET study shown above demonstrate the effectiveness of HETLIOZ in treating jet lag disorder. The magnitude of the total sleep time benefit of  minutes improvement over placebo is significant and clinically meaningful. The demonstration of benefits in measurements of next day alertness on both KSS and VAS is meaningful and it underscores the ability of HETLIOZ to address both nighttime and daytime symptoms of jet lag disorder.  Vanda previously reported on the JET study  that examined the effects of HETLIOZ in a circadian challenge of  hours advance of the subjects usual bedtime. The results of that study were published in The Lancet in .  The observation that HETLIOZ is effective in treating the symptoms caused by an abrupt advance of the circadian cycle of a magnitude of  or  hours suggests that HETLIOZ will be an effective therapeutic tool in the treatment of individuals that experience symptoms of jet lag. HETLIOZ will be potentially useful under circumstances of rapid eastward transmeridian travel experienced by frequent travelers the rapid deployment of military troops and any circumstances that will necessitate the abrupt phase advance of the sleep wake cycle. 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  million US residents make trips abroad each year to overseas destinations.  Of these  approximately  million travel to destinations in Europe Middle East and Asia.  It is also reported that  approximately . million travel in Business or First class.  We are extremely pleased with the outcome of this study which establishes the utility of HETLIOZ in the treatment of jet lag disorder as HETLIOZ was shown to overcome a significant circadian challenge of an  hour phase advance. This challenge is equivalent to eastward travel across  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 said Mihael H. Polymeropoulos MD Vandas President and CEO.  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 will likely represent an important commercial opportunity for the company.  For review of the current prescribing information of HETLIOZ please visit  http Conference Call  The Vanda management team will host a conference call and live webcast today March   at  AM ET to discuss these updates.  Investors can call  domestic or  international and use passcode . A replay of the call will be available on Monday March   beginning at  AM ET and will be accessible until Monday March   at  PM ET. The replay callin number is  for domestic callers and  for international callers. The passcode number is .  The conference call will be broadcast simultaneously on Vandas website. Investors should click on the Investor Relations tab and are advised to go to the website at least  minutes early to register download and install any necessary software or presentations. The call will also be archived on Vandas website for a period of  days. HETLIOZ IS NOT CURRENTLY APPROVED BY ANY REGULATORY AUTHORITY FOR THE TREATMENT OF JET LAG DISORDER. About HETLIOZ HETLIOZ is a melatonin receptor agonist. HETLIOZ has been granted market authorization by the U.S. Food and Drug Administration and the European Medicines Agency.  For full U.S. prescribing information please visit  http Important Safety Information The most common adverse reactions incidence  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  years patients than younger patients because exposure to HETLIOZ is increased by approximately fold compared with younger patients. Indication HETLIOZ is indicated for the treatment of NonHour SleepWake Disorder Non. 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  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  years patients than younger patients because exposure to HETLIOZ is increased by approximately fold compared with younger patients. Use of HETLIOZ should be avoided in combination with fluvoxamine or other strong CYPA 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 CYPA inducers because of a potentially large decrease in exposure of HETLIOZ with reduced efficacy. There are no adequate and wellcontrolled 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. About Vanda 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 Vanda Pharmaceuticals Inc. please visit  http  Abbreviations PSG                 Polysomnography TST                  Total Sleep Time LPS                  Latency to Persistent Sleep WASO              Wake After Sleep Onset KSS                  Karolinska Sleepiness Scale VAS                  Visual Analog Scale References . Rajaratnam SM Polymeropoulos MH Fisher DM Roth T Scott C Birznieks G Klerman E.  Melatonin agonist tasimelteon VEC for transient insomnia after sleeptime shift two randomized controlled multicenter trials.  The Lancet.    . . US Department of Commerce International Trade Administration National Travel and Tourism Office.  Profile of U.S. Resident Travelers Visiting Overseas Destinations  Outbound. httptinet.ita.doc.govoutreachpagesdownload_data_table_Outbound_Profile.pdf FORWARD LOOKING STATEMENTS Various statements in this release and to be made on the conference call are forwardlooking statements under the securities laws. Forwardlooking 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 Vandas forwardlooking statements include among others the ability of HETIOZ to provide significant benefit in the treatment of the symptoms of jet lag disorder Vandas 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 Managements Discussion and Analysis of Financial Condition and Results of Operations sections of Vandas annual report on Form K for the fiscal year ended December   which is on file with the SEC and available on the SECs website at  http In addition to the risks described above and in Vandas annual report on Form K other unknown or unpredictable factors also could affect Vandas results. There can be no assurance that the actual results or developments anticipated by Vanda will be realized or even if substantially realized that they will have the expected consequences to or effects on Vanda. Therefore no assurance can be given that the outcomes stated in such forwardlooking statements and estimates will be achieved. All written and verbal forwardlooking 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 forwardlooking 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 forwardlooking statements whether as a result of new information future events or otherwise. Corporate Contact Jim Kelly Executive Vice President and Chief Financial Officer  Vanda Pharmaceuticals Inc.     jim.kellyvandapharma.com mailtojim.kellyvandapharma.com  SOURCE Vanda Pharmaceuticals Inc. Related Links http"