ROCKVILLE, Md., March 31, 2011 /PRNewswire/ — Vanda
Pharmaceuticals Inc. (Nasdaq:
VNDA) today announced its plans to initiate a Phase IIb/III
clinical trial of tasimelteon in patients with Major Depressive
Disorder (MDD). The trial is expected to begin during the
second half of 2011. Tasimelteon is currently being evaluated
in Phase III clinical trials for the treatment of Non-24-Hour
Sleep/Wake Disorder (N24HSWD) in blind individuals without light
perception.
“Research suggests that misalignment of the circadian rhythm, or
body clock, may have significant health consequences, including
those related to mood disorders such as major depression,” said
Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO.
“Treating depression with a circadian regulator is a novel
concept, which has more recently become an area of focus for the
pharmaceutical industry. Expansion of our investigations into MDD
is consistent with our vision for Vanda as a leading specialty
pharmaceutical company focused on the development and
commercialization of differentiated products for central
nervous system disorders.”
There is considerable evidence that suggests circadian rhythm
disturbances are important in the pathophysiology of mood
disorders. Depressed patients often show altered circadian rhythms,
sleep disturbances, and diurnal mood variation. Chronotherapies,
including bright light exposure, have been successfully used to
treat seasonal and non-seasonal mood disorders. These observations
suggest that aberrations of the circadian clock may significantly
contribute to the production of the symptoms of MDD and therefore
treatments that aim at restoring the regulation of the circadian
clock could prove beneficial (1).
Despite the availability of a number of treatments for MDD,
there remains a significant unmet medical need. In the large
Star*D study spon
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