Duodart is indicated in the treatment of moderate-to-severe symptoms of benign prostatic hyperplasia (BPH) and reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate-to-severe symptoms of BPH.
GSK said that the regulatory submission for dutasteride and tamsulosin FDC was based on data from CombAT study, which showed that the combination of dutasteride and tamsulosin offers patients with moderate-to-severe symptoms of BPH.
The study showed superior and sustained symptom improvement compared with the most frequently prescribed medication, the alpha blocker tamsulosin. Symptom improvement that starts as rapidly as tamsulosin monotherapy and is sustained over 4 years.
Additionally, the study demonstrated a reduction in the risk of BPH complications – AUR and BPH related surgery vs tamsulosin by 66% and by 20% vs dutasteride (p=ns) monotherapy at 4 years. In the study, bioequivalence has been demonstrated between the fixed dose combination and the free combination.
Eddie Gray, president for pharmaceuticals in Europe at GSK, said: “Recognising the benefits of these two medicines and the significant proven benefit of their dual use, GSK developed this new fixed dose combination medicine to provide patients and physicians a convenient, once daily treatment, which reduces the impact of the bothersome symptoms of this common condition, and the risk of potential complications and related surgery. These are the factors which create uncertainty and anxiety for many men and may also lead to additional unplanned costs for healthcare providers.”