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news.France-based pharmaceutical company Servier has announced that its first melatonergic antidepressant, Valdoxan/Thymanax, has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its use in the treatment of adult patients with major depressive disorder.
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Upon approval by the European Commission in early 2009, Valdoxan is expected to be marketed by Servier in European countries in the following months.
Data from the company’s clinical development program 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 major depressive disorder. 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 company said.