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Vanda Pharmaceuticals Initiates Phase II
Clinical Trial for VSF-173 in Excessive Sleepiness
ROCKVILLE, Md.
April 25
Vanda Pharmaceuticals Inc. (Nasdaq:
VNDA), a biopharmaceutical company focused on the development and
commercialization of clinical-stage product candidates for central
nervous system disorders, today announced the initiation of a Phase
II clinical trial of its product candidate VSF-173 in excessive
sleepiness (ES).
The trial is a randomized, double-blind, placebo-controlled
study to investigate the efficacy and safety of three oral doses
of VSF-173
for the treatment of induced excessive sleepiness in approximately
60 healthy male and female subjects. The primary endpoint of the
study is the difference from placebo on the Maintenance of Wakefulness
Test (MWT), a standard measure of sleepiness.
About Excessive Sleepiness
Excessive sleepiness
(ES) is a common symptom that can significantly impair a person's
ability to function. The effects of ES range from
mild sleepiness to unrecognized episodes of "microsleeps" and
uncontrollable sleep attacks. Excessive sleepiness is a symptom
of many disorders including, obstructive sleep apnea, narcolepsy,
shift worker sleep disorder, Parkinson's, and Alzheimer's disease.
ES
may have significant consequences ranging from impairment in social
and occupational functioning to severe accidents. According
to the National Sleep Foundation 2005 Sleep in America Poll, 43%
of adults reported that they are so sleepy during the day that
it interferes with their daily activities a few days per month or
more
and 22% experience this level of daytime sleepiness at least a
few days per week. According to the same poll, 60% of adult drivers
say they have driven a vehicle while feeling drowsy in the past
year, and more than one-third of adult drivers have actually fallen
asleep at the wheel. ES make lapses of attention more likely to
occur, and may play a role in behavior that can lead to automobile
accidents.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
release contains forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended,
including statements regarding Vanda's plans for its product candidates.
Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and
similar expressions or words identify forward-looking statements.
Such forward-looking statements are based upon current expectations
that involve risks, changes in circumstances, assumptions and uncertainties.
Vanda is at an early stage of development and may not ever have
any products that generate significant revenue. Important factors
that could cause actual results to differ materially from those
reflected in Vanda's forward-looking statements include, among others,
a failure of Vanda's product candidates to be demonstrably safe
and effective, a failure to obtain regulatory approval for the company's
products or to comply with ongoing regulatory requirements, a lack
of acceptance of Vanda's product candidates in the marketplace,
a failure of the company to become or remain profitable, Vanda's
inability to obtain the capital necessary to fund its research and
development activities, a loss of any of the company's key scientists
or management personnel, and other factors that are described in
the "Risk Factors" section (Item 1A) of Vanda's annual
report on Form 10-K for the year ended December 31, 2006 (File No.
000-51863). No forward-looking statements can be guaranteed and
actual results may differ materially from such statements. The information
in this release is provided only as of the date of this release,
and Vanda undertakes no obligation to update any forward- looking
statements contained in this release on account of new information,
future events, or otherwise, except as required by law.
ABOUT VANDA
PHARMACEUTICALS INC.:
Vanda Pharmaceuticals Inc. is a biopharmaceutical
company focused on the development and commercialization of clinical-stage
product
candidates for central nervous system disorders. The company has
three product candidates in clinical development. Vanda's lead product
candidate, iloperidone, is a compound for the treatment of schizophrenia
and bipolar disorder and has recently completed its Phase III program
in schizophrenia. Vanda's second product candidate, VEC-162, is
a compound for the treatment of sleep and mood disorders which is
currently in Phase III for sleep disorders. Vanda's third product
candidate, VSF-173, is a compound for the treatment of excessive
sleepiness that is currently in a Phase II trial. For more on Vanda
Pharmaceuticals Inc., please visit http://www.vandapharma.com.
SOURCE
Vanda Pharmaceuticals Inc.
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