Valdoxan agomelatine: Phase III data

A double-blind, international Phase III trial in 515 patients showed that Valdoxan was superior to fluoxetine on the primary endpoint of mean change from baseline in HAM-D17 vs. placebo at 8 weeks (1.49 point difference, p=0.024). Valdoxan also led to a significantly higher percentage of responders on the CGI rating scale compared with fluoxetine (77.7% vs. 68.8%, p=0.023). The percentage of patients with at least 1 adverse event was similar between the two groups. Data were presented at the European College of Neuropsychopharmacology meeting in Istanbul. ...