The first melatonergic antidepressant – Valdoxan®/Thymanax® (agomelatine) – has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its use in the treatment of adult patients with major depressive disorder (MDD).

Upon approval by the European Commission in early 2009, Valdoxan is expected to be marketed by Servier in European countries in the following months.

Valdoxan is an innovative, new approach to the treatment of MDD, and has proven efficacy across a wide range of patients, including the most severely depressed. The new drug, Valdoxan, compares favourably with the most currently-prescribed antidepressants and offers new hope to the 33 million people in Europe who suffer from MDD, a disease for which there is still a significant medical need for improved management of patients' depressive symptoms.

Evidence of Valdoxan's antidepressant efficacy

Data from its clinical development programme show that Valdoxan is effective against the core symptoms of depression, including depressed mood, anxiety, psychomotor retardation, sleep disturbances, and daytime fatigue, leading depressed patients to a more complete and sustained remission.

Valdoxan has proven efficacy in moderately and severely adult depressed patients (18-65 years old) presenting a first or recurrent episode of MDD. Valdoxan has been demonstrated to be effective at every step of depression treatment, with significant early improvement reported by both clinicians and patients as soon as the first week of treatment.

The antidepressant efficacy has been shown at a once-daily dose of 25 mg in most patients. Both short-term and long-term results from the large, comprehensive, international development programme including nearly 4000 adult patients with MDD were presented to the CHMP to support the efficacy of Valdoxan as compared with placebo, selective serotonin reuptake inhibitors (SSRIs), and serotonin noradrenaline reuptake inhibitor (SNRI) treatments. This programme also showed that Valdoxan's antidepressant efficacy was combined with a favourable tolerability profile compared with other treatments, resulting in better adherence and remission in depressed patients.