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Vanda Announces Phase IIb/III Clinical Study In Major Depressive Disorder Did Not Meet The Primary Endpoint
Date:1/31/2013

WASHINGTON, Jan. 31, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) today announced top-line results of the Phase IIb/III clinical study (MAGELLAN) in Major Depressive Disorder (MDD), investigating the efficacy and safety of tasimelteon as a monotherapy in the treatment of patients with MDD.  The clinical study did not meet the primary endpoint of change from baseline in the Hamilton Depression Scale (HAMD-17) after 8 weeks of treatment as compared to placebo.  Both tasimelteon and placebo treated patients had an approximately 40% reduction of their MDD symptoms from baseline.  Tasimelteon was shown to be safe and well-tolerated, consistent with observations in prior studies.  Given these current proof of concept clinical study results, Vanda has decided to discontinue all activities in this indication.

"These results are disappointing, as there is still a significant unmet medical need for patients with Major Depression," said Mihael H. Polymeropoulos , M.D., President and CEO of Vanda.  "Tasimelteon's application in the treatment of blind individuals with Non-24 remains our top priority as we pursue our planned NDA submission this year."     

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 U.S. Food and Drug Administration in mid-2013.

About MAGELLAN

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. 


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SOURCE Vanda Pharmaceuticals Inc.
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