GlaxoSmithKline (GSK) announced that the Swiss regulatory authority, Swissmedic, has granted approval for Duodart, a fixed dose combination (FDC) of dutasteride (0.5mg) and tamsulosin (0.4mg). Dutasteride and tamsulosin FDC is indicated for the treatment of men with 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 BPH2.
"This positive decision by Swissmedic is a significant milestone for Duodart, as it is the first approval in Europe. We look forward to subsequent approvals and launches across Europe during 2010." said Eddie Gray, president Pharmaceuticals Europe, GSK.
The regulatory submission for dutasteride and tamsulosin FDC was based on data from the CombAT study.
CombAT showed that combination therapy with dutasteride and tamsulosin offers patients with moderate-to-severe symptoms of BPH.
Significantly superior and sustained symptom improvement compared with the most frequently prescribed medication, the ?-blocker tamsulosin. Symptom improvement that starts as rapidly as tamsulosin monotherapy and is sustained over four years. A significant reduction in the risk of BPH complications - AUR and BPH related surgery vs. tamsulosin by 66 per cent (p<0.001)and by 20 per cent vs. dutasteride (p=NS)monotherapy at four years. Significantly superior at reducing the relative risk of BPH clinical progression compared to both monotherapies. (Bioequivalence has been demonstrated between the fixed dose combination and the free combination). Tamsulosin is not indicated to reduce the risk of AUR or BPH-related surgery.
The combination therapy was generally well-tolerated and most reported drug-related adverse events were as anticipated from the known safety profiles of the two drugs, with erectile dysfunction and retrograde ejaculation as the most commonly reported drug-related adverse events. However, the incidence of cardiac failure observed was higher in the combination arm (0.9 per cent) than in the tamsulosin arm (0.6 per cent) and the dutasteride arm (0.2 per cent). There was no difference in overall cardiovascular events across treatment groups.
The four year combination therapy with Avodart and Tamsulosin (CombAT) study was a multinational randomised study of 4,844 men at increased risk of BPH progression, which investigated whether combination treatment with the 5?-reductase inhibitor (5ARI), dutasteride (0.5mg), and an ?-blocker, tamsulosin (0.4mg), was more effective than either monotherapy in improving symptoms and clinical outcomes in men with moderate-to-severe symptomatic BPH2.