Istanbul, Turkey, 15th September 2009 – Further evidence of the superior antidepressant efficacy of Valdoxan®/Thymanax® (agomelatine) over conventional selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitor (SNRI) antidepressants was presented today at the Servier satellite symposium on the occasion of the 22nd European College of Neuropsychopharmacology (ECNP) Congress, with educational financial support provided [...]

Valdoxan 25 mg film-coated tablets
Agomelatine
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1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
[...]

1. What is the clinical proof of VALDOXAN’s antidepressant efficacy?
The antidepressant efficacy of VALDOXAN has been confirmed in four trials versus placebo, three over the short term and one over the long term. The antidepressant efficacy of VALDOXAN is significantly superior to that of placebo, as mentioned in the Valdoxan SPC, whatever the symptom intensity, [...]

Valdoxan is a novel antidepressant indicated in the treatment of major depressive episodes in adults. The recommended dose of Valdoxan is 1 tablet of 25 mg once daily, taken orally at bedtime. After 2 weeks of treatment, if there is no improvement of symptoms, the dose of Valdoxan may be increased to 50 mg once [...]

Valdoxan is effective whatever the intensity of depressive symptoms. The efficacy of Valdoxan was observed in the more severely depressed patients (baseline HAM-D ≥ 25) in all positive placebo-controlled studies.
Efficacy of Valdoxan in severe depression
Results of the meta-analysis of three positive, randomized, double-blind, placebo controlled studies in 357 patients treated with Valdoxan and 360 patients [...]

Valdoxan provides MDD patients with a significant symptomatic relief, as demonstrated by well-documented improvements in depressed mood, anxiety symptoms, and also sleep-wake disturbances (daytime impairment and sleep disturbances).
Efficacy of Valdoxan on depressed mood
Valdoxan has been demonstrated to be significantly effective in relieving depressed mood of patients with MDD, the most characteristic symptom of depression.
In a [...]

A Long-term efficacy of Valdoxan: prevention of relapses at 6 months
The maintenance of antidepressant efficacy of Valdoxan was demonstrated over a treatment period of 6 months in a relapse prevention study. Patients responding to 8/10-weeks of acute treatment with open-label Valdoxan 25 to 50 mg once daily were randomized to either Valdoxan 25 or 50 [...]

Valdoxan’s onset of efficacy has been reported and measured on the Clinical Global Impression-Improvement [CGI-I] scale and Visual Analog Scales [VAS]as early as the first week of treatment. From the first week of treatment, Valdoxan demonstrated to provide significant efficacy in terms of CGI score improvement, as well as VAS score improvement.
Significant improvement in CGI [...]