First-in-class antidepressant prevents relapse

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The Pharmaceutical Journal
Vol 279 No 7478 p555
17 November 2007

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First-in-class antidepressant prevents relapse

Agomelatine in Europe

Last year (2006) the European Medicines Agency (EMEA) refused to grant a marketing authorisation for agomelatine for treatment of major depressive disorder because, it said, the drug’s “effectiveness had not been sufficiently shown”.

Servier Laboratories, manufacturer of agomelatine, has resubmitted a registration file to the EMEA for consideration.

A new type of antidepressant could help to prevent patients from relapsing. First-in-class agomelatine acts as an agonist at melatonergic MT₁/MT₂ receptors and as an antagonist at 5-HT_2C receptors.

New data presented at the European College of Neuropsychopharmacology annual congress, held in Vienna last month, suggest a 54 per cent relative reduction in risk of relapse of depression for agomelatine-treated patients.

A total of 492 patients with depression received open-label agomelatine (25–50mg) for eight to 10 weeks, after which those who responded were randomised to receive either agomelatine (n=165) or placebo (n=174) for a 24-week period.

The researchers saw a significantly lower incidence of relapse over six months for patients who continued taking agomelatine than for those swapped to placebo (21.7 versus 46.6 per cent; P=0.0001).

The percentage of patients with at least one adverse effect was similar between groups, with headache, nasopharyngitis and back pain being the most common side effects reported.