Posted by Netch on February 25, 2009, at 9:22:52
Agomelatine Approved in EU for Major Depressive Episodes:
The European Commission has granted marketing authorisation for agomelatine (Valdoxan) for the treatment of adult patients with major depressive episodes.
The approval is based on both short-term and long-term results from a large, comprehensive, international development programme including almost 6,000 adult patients with depression.
The results demonstrated the superior efficacy of agomelatine as compared with placebo, selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitor (SNRI) treatments.
Agomelatine was effective in moderately and severely depressed adult patients (18-65 years) presenting a first or recurrent episode of depression. Clinical improvement was seen within the first week of treatment, as reported by physicians and patients.
The drug was effective against all the core symptoms of depression including depressed mood, anxiety, feeling of guilt, psychomotor retardation, sleep disturbances, and daytime fatigue.
Valdoxan granted authorisation for treatment of depressive episodes:
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.