HETLIOZ™ (tasimelteon) Data in Patients with Non-24-Hour Sleep-Wake Disorder
to be presented at SLEEP 2014 meeting
WASHINGTON, June 2, 2014
WASHINGTON, June 2, 2014 /PRNewswire/ --Vanda Pharmaceuticals Inc. (Vanda)
(NASDAQ: VNDA) will present additional data from its HETLIOZ™ (tasimelteon)
clinical development program at SLEEP 2014, the 28th Annual Meeting of
Associated Professional Sleep Societies in Minneapolis, Minnesota.
HETLIOZ^TM data at SLEEP 2014 will be presented in one oral and six poster
sessions. The data presentation schedule is as follows:
oJune 4^th at 2:15 – 2:30pm, Assessment of clinical measures in Non-24
Disorder in Patients Entrained by Tasimelteon with Dr. Steven Lockley
oJune 2^nd at 4 – 6pm
oPoster 74 Evaluation of the effect of concomitant consumption of
tasimelteon and ethanol on cognitive function, balance, and
subjective measures in healthy subjects
oJune 4^th at 10am – 12:20pm – Posters
o122 Causes of total blindness associated with Non-24-Hour Disorder
o124 Assessment of Potential for Withdrawal or Abuse with the use of
the circadian regulator tasimelteon
o123 Tasimelteon a novel treatment for Non-24 Hour Disorder: Pooled
safety analysis of two Phase II and two Phase III placebo controlled
o125 LQ-nTST, UQ-dTSD, and MoST: Circadian Specific Sleep/Wake
Measures for Non-24 Patients
o126 Phase Analysis of nighttime total sleep time and daytime total
sleep duration in patients with Non-24-Hour Disorder
About 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. The sleep
disturbance causes significant distress or impairment in social, occupational
and other important areas of functioning. Non-24 affects the majority of
totally blind individuals and it is estimated that approximately 80,000
Americans have the disorder.
HETLIOZ™ is a melatonin receptor agonist. HETLIOZ™ has been approved by the
U.S. Food and Drug Administration for the treatment of Non-24-Hour Sleep-Wake
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
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
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
Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com.
AboutVanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc.is a biopharmaceutical company focused on the
development and commercialization of products for the treatment of central
nervous system disorders. For more on Vanda, please visit
U.S. full prescribing information for HETLIOZ™ is available at
HETLIOZ™ is a registered trademark of Vanda Pharmaceuticals Inc.
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
Assistant Vice President
SOURCE Vanda Pharmaceuticals Inc.
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