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Green light for combination BPH pill

By Gareth Iacobucci

The first drug to offer two individual therapies for benign prostatic hyperplasia (BPH) in one pill has been approved for use in the UK.

GlaxoSmithKline’s Combodart – a new once-daily combination pill, is being introduced to combat disease progression and provide symptom relief.

The treatment – a fixed-dose combination of the 5-alpha reductase inhibitor dutasteride and the alpha blocker tamsulosin hydrochloride – has been cleared by regulators to treat moderate-to-severe BPH and reduce the risk of acute urinary retention (AUR) and BPH-related surgery.

The drug has been approved following a clinical trial which showed that the combination of Combodart reduced the risk of AUR or BPH-related surgery by 66% compared with tamsulosin alone, and that the combo also cut the risk of disease progression by 44% versus tamsulosin and 31% compared with dutasteride alone.