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 by Servier. The new data demonstrates superior antidepressant efficacy over the SSRI fluoxetine, in severely depressed patients.¹

This new data, in addition to the results of the international development programme in over 6,000 patients and initial feedback from countries in which it is launched, confirm that Valdoxan®, the first melatonergic antidepressant, has superior antidepressant efficacy at every step of treatment in all depressed patients. This superior efficacy, combined with a good tolerability profile makes Valdoxan® the first line treatment of choice for depression, whatever the severity of disease.

“These results, coupled with the existing robust evidence on the efficacy of Valdoxan®, show that this new antidepressant offers an important alternative for the treatment of depression, including in its severe forms”, says leading depression expert Professor Sidney Kennedy, Psychiatrist-in-Chief of the University Health Network and Professor of Psychiatry, University of Toronto, Canada. “Despite the availability of a wide range of existing antidepressants, there are clear unmet needs in the management of depression. Valdoxan®, with its innovative mode of action, represents a totally new approach to the management of Major Depressive Disorder and will hopefully offer a brighter future for depressed patients.”

New data¹

The study was designed to demonstrate the superior antidepressant efficacy of agomelatine compared to the SSRI fluoxetine, in severely depressed patients. It was a randomised, multinational, double-blind study carried out in 515 patients presenting with a current severe episode of Major Depressive Disorder (MDD). Depression severity was defined on two standard depression rating scales, the HAM-D₁₇ and CGI-Severity of Illness. To be included in the study, patients had to have a HAM-D₁₇ score greater than or equal to 25 combined with CGI-Severity of Illness score greater than or equal to four.

Patients were split into two groups, receiving either agomelatine 25 mg / 50 mg or fluoxetine 20 mg / 40 mg for an eight-week period (adjustment to the higher dose of each drug was possible after two or four weeks respectively).

Agomelatine antidepressant efficacy was significantly superior to that of fluoxetine (P=0.024), with a difference between treatment in favour of agomelatine at last post-baseline value of 1.49 point on HAM-D₁₇. The superiority of agomelatine compared to fluoxetine was also shown by statistically significant higher percentages of responders on HAM-D₁₇ (defined as a decrease from baseline total score ≥ 50%) over the trial period 71.7% of the patients responded to treatment in the agomelatine group compared to 63.8% in the fluoxetine group (P=0.060). The superiority of agomelatine compared to fluoxetine was again shown on the CGI-Improvement rating scale, a rating scale reflecting clinical judgement and therefore daily clinical practice, with a statistically higher percentage of responders (CGI-I score = 1 or 2; P=0.023) in the agomelatine group (77.7%) than in the fluoxetine group (68.8%).

For those patients, the superior antidepressant efficacy Valdoxan® means a unique relief of depressive symptoms, as well as major improvements in their professional, family and social life.

Valdoxan® international development programme

The efficacy of Valdoxan® in MDD has been shown in several clinical trials within the international development programme. This programme demonstrated the superior efficacy of Valdoxan® as compared with placebo, SSRIs and SNRI treatments. Results of the studies showed that:

- Valdoxan® offers superior antidepressant efficacy in all depressed patients, whatever the severity of depression¹
- Valdoxan® offers superior antidepressant efficacy at every step of depression treatment, showing superior patient improvement within the first week of treatment, as reported by both physicians and patients themselves^2,3
- Valdoxan® is effective against all the core symptoms of depression, including depressed mood, anxiety, feeling of guilt, psychomotor retardation, sleep disturbances, and daytime fatigue, leading depressed patients to a more complete and sustained remission⁴
- Valdoxan® significantly reduces the incidence of relapse in depressive patients over the long term³
- Valdoxan® preserves sexual functioning, is weight neutral and offers a favourable tolerability profile, thus resulting in better adherence and remission in depressed patients⁵
- Valdoxan® is easy to use: one 25 mg tablet taken at bedtime, without discontinuation symptoms at the end of treatment⁶

Valdoxan®: a major therapeutic advance in management of depression through the restoration of circadian rhythms

Valdoxan® is the result of an advanced pharmacological research programme involving investigation centres all around the world. It is the first antidepressant that simultaneously acts as a MT₁ and MT₂ melatonergic receptors agonist and a 5-HT_2C antagonist. As a result, Valdoxan® resynchronises circadian rhythms that are profoundly disrupted in depressed patients.⁷

“Valdoxan® has the potential to relieve the symptoms of depression with a fast onset of action and reduced risk of significant adverse effects,” points out Doctor Philip Gorwood, Professor of Psychiatry at Sainte Anne Hospital, Paris, France. “It has a novel mechanism of action unlike those of the commonly-prescribed antidepressants, the SSRIs and SNRIs, as Valdoxan® exerts its antidepressant efficacy without having an impact on serotonin levels”.

Valdoxan® was discovered and developed by Servier, France’s leading independent pharmaceutical company. Valdoxan® received EU marketing authorisation in February 2009 and is now available in several countries worldwide for the treatment of adult patients with MDD.

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