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|Vanda Announces Phase IIb/III Clinical Study In Major Depressive Disorder Did Not Meet The Primary Endpoint|
"These results are disappointing, as there is still a significant unmet medical need for patients with Major Depression," said
Vanda has recently reported positive results in two phase III clinical studies of tasimelteon in Non-24-Hour Disorder (Non-24) and plans to submit a New Drug Application to the
MAGELLAN was a proof of concept, two arm (tasimelteon 20mg and placebo), 8-week, double-masked, randomized, phase IIb/III clinical study in patients with MDD. The study enrolled 507 patients in 43 sites in the U.S. The primary endpoint of the study was the change from baseline in the Hamilton Depression Scale (HAMD-17) at week 8.
Tasimelteon is a circadian regulator in development for the treatment of Non-24. Tasimelteon is a melatonin agonist of the human MT1 and MT2 receptors, with greater specificity for MT2. Tasimelteon's ability to reset the master body clock in the suprachiasmatic nucleus (SCN), located in the hypothalamus, results in the entrainment of the body's melatonin and cortisol rhythms to align to the 24-hour day-night cycle. Tasimelteon is currently in Phase III development for Non-24. A New Drug Application, is expected to be submitted to the
The conference call will be broadcast simultaneously on Vanda's website, http://www.vandapharma.com. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download and install any necessary software. The call will also be archived on Vanda's website for a period of 30 days, through
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