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