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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.
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,
million people in Europe suffering from major depressive episode. Valdoxan’s
tolerability profile is a result of its unique receptor profile. Valdoxan is
the first antidepressant with melatonin receptor (MT1) and (MT2) agonist
antagonist properties. This unique receptor profile of Valdoxan allows for
results from a large, comprehensive, international development programme
selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline
- Valdoxan is easy to use from beginning to end: a simple dose of one 25
"Valdoxan has the potential to relieve the symptoms of depression with a
reduced risk of significant adverse effects," said Professor Goodwin. "With
noticeable clinical improvement as early as the first week of treatment,
Valdoxan represents an advance for depressed patients who today expect a more
Valdoxan: a major therapeutic advance in management of depression through
Valdoxan is the result of an advanced pharmacological research programme
resynchronises circadian rhythms that are profoundly disrupted in depressed
commonly-prescribed antidepressants, the SSRIs and SNRIs, as Valdoxan exerts
its antidepressant efficacy without having an impact on serotonin levels,"
pointed out Professor Racagni from the University of Milan, Italy.
The recommended dose of Valdoxan is one tablet of 25 mg taken once daily,
orally at bedtime.
Following approval from the European Commission, Valdoxan is expected to
become commercially available in European countries in the coming months.
independent pharmaceutical company.
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