The European College of Neuropsychopharmacology Congress (ECNP) highlighted new data regarding the high efficiency of Valdoxan® (agomelatine) in comparison with other commonly prescribed antidepressants showing that the drug is stronger and therefore significantly more beneficial for depressed patients with severe anxiety symptoms. Valdoxan®, available in over 40 countries worldwide was authorized in the EU in February 2009 for treatment of adult patients with MDD.

The new data is based on the analysis on the total of nearly 2,000 patients with major depressive disorder (MDD) from six large multi-center studies, each lasting between 6 and 8 weeks. Participants’ depression levels were measured by a score of at least 5 points on the anxiety subscale of the Hamilton Depression Rating Scale (HAM-D), which identified 900 of the total patients as being severely anxious.

Research was split into different study groups, including three of the six studies comparing Valdoxan to the selective serotonin reuptake inhibitors (SSRIs) sertraline and fluoxetine, and the serotonin noradrenalin reuptake inhibitor (SNRI) venlafaxine, with the remaining three studies comparing Valdoxan to placebo.

Prof. Dan Stein, Professor and Chair of the Dept. of Psychiatry and Mental Health at the University of Cape Town in South Africa explained:

“These new data are important, because anxiety within depression is common and associated with worse prognosis, increased disability and higher use of medication. This new evidence establishes the novel antidepressant agomelatine as a promising treatment option for the management of anxiety in patients suffering from depression.”

Researchers found that Valdoxan reduced anxiety scores in the HAM-D anxiety sub-score as early as the second week (p<0.004) compared to placebo. The fast improvement produced a significant efficacy over the entire study period (p<0.001), which was even higher in more anxious patients (p<0.001). Compared to the other drugs in the study, Valdoxan proved to be more effective in reducing anxiety symptoms and produced a substantial difference on the Hamilton Anxiety Rating Scale (HAM-A) of 1.39 points (p=0.006). Compared to the most commonly prescribed antidepressants, Valdoxan’s beneficial effects were even greater in highly anxious depressed patients, recording a difference of 1.72 on the HAM-A Scale (p=0.032). Prof. Sidney Kennedy, Professor of Psychiatry at the University of Toronto in Canada pointed out:

“In addition to the strong existing evidence of its antidepressant efficacy, these new data reinforce agomelatine’s powerful efficacy for the management of anxiety versus other commonly used antidepressants. In addition, this efficacy is seen in clinical settings with patients reporting ‘feeling better’ and being ‘less anxious’ as early as the second week of treatment.”

As the first antidepressant simultaneously acting as MT1 and MT2 melatonergic receptors agonist and a 5-HT2C antagonist, Valdoxan re-synchronizes circadian rhythms that are heavily disrupted in depressed patients, offering a totally innovative alternative to treating depression.

Clinicians can achieve greater efficacy with Valdoxan in reducing depression and anxiety symptoms in patients suffering from depression, including those with marked anxiety symptoms, because Valdoxan is the first antidepressant with a non-monoaminergic component.

Several clinical trials within the international development program have displayed Valdoxan’s efficacy in major depressive disorder (MDD). This study, consisting of nearly 6,000 depressed patients, indicated Valdoxan’s unique clinical signature and its distinctive profile compared with placebo, SSRIs and SNRI treatments.

Results of the studies demonstrated that Valdoxan:

  • is more efficient in the treatment of all stages of depression compared with conventional antidepressants, showing greater patient improvement following the first week of treatment, irrespective of the intensity of depressive symptoms even in the more severely depressed patients
  • produces a significant reduction of relapse incidence in depressive patients over the long-term
  • does not affect sexual functioning and weight, offering a favorable tolerability profile, leading to better adherence and remission in depressed patients
  • is easily administered: one 25 mg tablet taken at bedtime, without discontinuation symptoms at the end of treatment

Written by Petra Rattue