GlaxoSmithKline (GSK) has gained regulatory approval in Sweden for the co-administration of Avodart with tamsulosin to treat patients with moderate to severe benign prostatic hyperplasia symptoms.

Avodart, GSK's 5?-reductase inhibitor (5ARI), is the only dual acting 5ARI, in combination with tamsulosin, a widely prescribed a-blocker, for the treatment of patients with moderate-to-severe benign prostatic hyperplasia (BPH) symptoms. Approval was granted through the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State. Further approvals are anticipated in the coming months across a further 26 European countries, the company said.

The approval was based on positive two year results from the ongoing Combination of Avodart and Tamsulosin (CombAT) study, which showed that combination therapy with dutasteride and tamsulosin provides significantly superior and sustained improvements over two years in symptoms1, peak urinary flow (Qmax) and quality-of-life2 versus either monotherapy, in men with moderate-to-severe BPH symptoms.

The combination of dutasteride and tamsulosin has also been shown to provide significantly superior and sustained improvements in BPH symptoms versus dutasteride alone from month 3 and versus tamsulosin alone from month 9. This is the first time combination therapy has been shown to provide superior BPH symptom improvement versus both monotherapies in less than 1 year.

"For patients with BPH whose disease is worsening and whose symptoms are moderate-to-severe, the co-administration of Avodart and tamsulosin offers the benefits of both medicines, and provides doctors with an effective treatment option", said Dr Alastair Benbow, vice president and European Medical Director, GSK.

Avodart is the only BPH treatment that inhibits both type 1 and type 2 5?-reductase isoenzymes, blocking the conversion of testosterone into the primary male hormone, dihydrotestosterone (responsible for prostate growth and BPH development), providing long-term symptom improvement, and reducing the risk of BPH complications (AUR and surgery).

Tamsulosin is a widely prescribed ?-blocker, which provides a rapid onset of urinary symptom relief by reducing the smooth muscle tone in the prostate and bladder neck, although other mechanisms of action might also exist.