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Valdoxan(R) Granted Marketing Authorisation for the Treatment of Major Depressive Episodes in Europe
Date:2/24/2009

PARIS, January 24 /PRNewswire/ -- The European Commission has granted marketing authorisation for Servier's Valdoxan(R) /Thymanax(R) (agomelatine), the first melatonergic antidepressant for the treatment of adult patients with major depressive episodes.

"There is still great scope for improved therapies to treat the devastating effects of depression," said Professor Goodwin from Warneford Hospital, Oxford, United Kingdom. "Valdoxan is an innovative, new approach to the management of depression that compares favourably to existing treatments. It has proven, sustained efficacy across a wide range of depressed patients, including those who are most severely depressed."

Valdoxan, one 25 mg tablet taken at bedtime, offers new hope for the 33 million people in Europe suffering from major depressive episode. Valdoxan's powerful antidepressant efficacy combined with its good safety and tolerability profile is a result of its unique receptor profile. Valdoxan is the first antidepressant with melatonin receptor (MT1) and (MT2) agonist properties and 5-hydroxytryptamine (serotonin) receptor 2C (5-HT2C) antagonist properties. This unique receptor profile of Valdoxan allows for the first time the restoration of the circadian rhythms of depressed patients.(1)

Valdoxan: significant antidepressant efficacy from the start to the end of treatment

The European approval of Valdoxan is based on both short and long-term results from a large, comprehensive, international development programme including almost 6,000 adult patients with depression. The results demonstrate the superior efficacy of Valdoxan as compared with placebo, selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitor (SNRI) treatments and also show that:

    - Valdoxan has proven efficacy whatever the intensity of symptoms, in
      moderately and severely depressed adult patients 
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SOURCE Servier
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