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.
HETLIOZTM data at SLEEP 2014 will be presented in one
oral and six poster sessions. The data presentation schedule is as
follows:
Oral Presentation
- June 4th at 2:15 –
2:30pm, Assessment of clinical
measures in Non-24 Disorder in Patients Entrained by Tasimelteon
with Dr. Steven Lockley
Poster Presentations
- June 2nd at 4 –
6pm
- Poster 74 Evaluation of the effect of
concomitant consumption of tasimelteon and ethanol on cognitive
function, balance, and subjective measures in healthy
subjects
- June 4th at
10am – 12:20pm – Posters
- 122 Causes of total blindness associated with
Non-24-Hour Disorder
- 124 Assessment of Potential for Withdrawal or Abuse
with the use of the circadian regulator tasimelteon
- 123 Tasimelteon a novel treatment for Non-24 Hour
Disorder: Pooled safety analysis of two Phase II and two Phase III
placebo controlled studies
- 125 LQ-nTST, UQ-dTSD, and MoST: Circadian Specific
Sleep/Wake Measures for Non-24 Patients
- 126 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.
About HETLIOZ™
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 Disorder (Non-24).
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™
Indication
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.
Full HETLIOZ™ Prescribing Information can be found at:
www.hetlioz.com.
About Vanda 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 www.vandapharma.com.
U.S. full prescribing information for HETLIOZ™ is available
at www.HETLIOZ.com.
HETLIOZ™ is a registered trademark of Vanda Pharmaceuticals
Inc.
Corporate Contact:
Jim Kelly
Senior Vice
President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contact:
Laney Landsman
Assistant Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com
SOURCE Vanda Pharmaceuticals Inc.