Lilly's ED drug Cialis meets endpoint in LUTS/BPH study

US drug major Eli Lilly (NYSE: LLY) presented results yester day at the annual European Association of Urology (EAU) Congress in Milan, Italy, of a study that showed Cialis (tadalafil) 5mg once daily co-administered with finasteride significantly improved scores on the International Prostate Symptom Score (IPSS), compared to placebo/finasteride, in men with lower urinary tract symptoms of benign prostatic hyperplasia (LUTS/BPH) and enlarged prostates.

On a pre-specified secondary measure, Cialis and finasteride (Merck & Co’s off-patent BPH drug Proscar) also improved erectile function scores versus placebo/finasteride in those men who had both LUTS/BPH and erectile dysfunction (ED) at baseline. Cialis is already approved in the USA and Europe for the treatment of BPH (The Pharma Letters October 7, 2011 and October 31, 2012). This is the first study to report co-administration of Cialis and finasteride in men with LUTS/BPH.

"Symptomatic improvement with 5-ARI therapy (finasteride) is observed after six to 12 months of treatment; therefore, the study aimed to understand if men with prostatic enlargement experience earlier improvement of BPH symptoms when tadalafil is co-administered with a 5-ARI therapy," said Claus Roehrborn, chairman, Department of Urology, The University of Texas Southwestern Medical Center, who presented the results during the EAU Congress. "These results can help prescribers make better informed decisions when treating their patients," he added.