Valdoxan granted marketing authorisation for the treatment of major depressive episodes in Europe

Feb 24 2009

The European Commission has granted marketing authorisation for Servier's Valdoxan/Thymanax (agomelatine), the first melatonergic antidepressant for the treatment of adult patients with major depressive episodes.

"There is still great scope for improved therapies to treat the 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, including those who are most severely depressed."

Valdoxan, one 25 mg tablet taken at bedtime, offers new hope for the 33 million people in Europe suffering from major depressive episode. Valdoxan's powerful antidepressant efficacy combined with its good safety and tolerability profile is a result of its unique receptor profile. Valdoxan is the first antidepressant with melatonin receptor (MT1) and (MT2) agonist properties and 5-hydroxytryptamine (serotonin) receptor 2C (5-HT2C) antagonist properties. This unique receptor profile of Valdoxan allows for the first time the restoration of the circadian rhythms of depressed patients.

Valdoxan: significant antidepressant efficacy from the start to the end of treatment

The European approval of Valdoxan is based on both short and long-term results from a large, comprehensive, international development programme including almost 6,000 adult patients with depression. The results demonstrate the superior efficacy of Valdoxan as compared with placebo, selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitor (SNRI) treatments and also show that:

• Valdoxan has proven efficacy whatever the intensity of symptoms, in moderately and severely depressed adult patients (18-65 years old) presenting a first or recurrent episode of depression
• Valdoxan has demonstrated efficacy at every step of depression treatment, showing superior clinical improvement within the first week of treatment, as reported by both physicians and patients,
• 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 remission
• Valdoxan has been proven to significantly reduce the incidence of relapse in depressive patients over the long term
• Valdoxan preserves sexual functioning, is weight neutral and offers a favourable tolerability profile, thus resulting in better adherence and remission in depressed patients
• Valdoxan is easy to use from beginning to end: a simple dose of one 25 mg tablet taken orally at bedtime, without discontinuation symptoms at the end of treatment.

"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 complete remission."

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-HT2C antagonist. As a result, Valdoxan resynchronises circadian rhythms that are profoundly disrupted in depressed patients.

"Valdoxan's mechanism of action is unlike those of the 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.