When Two Plus Two Must Not Equal Four
June 2011
in “
British Journal of Urology
”
TLDR Regulatory challenges make developing combination therapies in urology difficult and costly.
The document discussed the challenges and limited success of combination drug studies in the urological field, particularly for benign prostatic hyperplasia (BPH) and erectile dysfunction. Despite evidence supporting the efficacy of combining 5-α-reductase inhibitors with α-blockers, regulatory requirements and high costs deterred pharmaceutical companies from pursuing these combinations. The "combination rule" required that the combined effect exceed individual components, complicating trials. Bayer's study on combining a phosphodiesterase inhibitor with a soluble guanylate cyclase activator aimed to enhance efficacy, but faced similar hurdles. The document concluded that regulatory and economic barriers hindered the development of combination therapies, suggesting that patient advocacy might be necessary to drive change.
