Combination treatment for BPH approved

July 14, 2008

Tamsulosin and dutasteride combination approved by FDA.

Combination treatment with the alpha blocker tamsulosin (Flomax, Boehringer Ingelheim) and 5-alpha reductase inhibitor dutasteride (Avodart, GSK) has received approval for a new indication: treatment of symptomatic enlarged prostate or benign prostatic hyperplasia (BPH). The approval was based on results from the CombAT (Combination of Avodart and Tamsulosin) trial which showed use of both drugs was superior to both monotherapies at 12 months and continued up through 24 months. Efficacy was measured as a reduction in the International Prostate Symptom Score (IPSS).