|FDA Approves HETLIOZ™ (tasimelteon) for the Treatment of Non-24-Hour Sleep-Wake Disorder|
Non-24 was first described more than 60 years ago, and is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. Non-24 affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have the disorder.
The approval of HETLIOZ™ was based on two key efficacy studies and the safety has been evaluated in over 1,300 individuals.
The most common adverse reactions in the clinical trials were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection. After taking HETLIOZ™, patients should limit their activity to preparing for going to bed because HETLIOZ™ can impair the performance of activities requiring complete mental alertness.
"Totally blind people have struggled with the problems brought on by Non-24-Hour Sleep-Wake Disorder, sometimes for their entire life, without understanding what causes it and without being able to do anything about it," said
Vanda anticipates making HETLIOZ™ commercially available in the second quarter of 2014.
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Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com
For more information about HETLIOZ™ call 1-844-HETLIOZ (1-844-438-5469).
Indication and Important Safety Information About HETLIOZ™
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 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, 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.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release are "forward-looking statements" under the securities laws. Words such as, but not limited to, "believe," "expect," "anticipate," "estimate," "intend," "plan," "project," "target," "goal," "likely," "will," "would," and "could," or the negative of these terms and similar expressions or words, identify forward-looking statements. 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: Vanda's ability to successfully commercialize (alone or with others) HETLIOZ™ in the U.S., uncertainty as to the market awareness of Non-24 and the market acceptance of HETLIOZ™, Vanda's dependence on third-party manufacturers to manufacture HETLIOZ™ in sufficient quantities and quality, Vanda's limited sales and marketing infrastructure, 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.
HETLIOZ™ is a registered trademark of