Eli Lilly ED drug Cialis meets primary endpoint in Phase III study

18th March 2013 (Last Updated March 18th, 2013 18:30)

Eli Lilly and Company has announced that its Phase III study of Cialis (tadalafil) co-administered with finasteride, has met its primary endpoint in men with lower urinary tract symptoms of benign prostatic hyperplasia (LUTS/BPH) and enlarged prostate.

Eli Lilly

Eli Lilly and Company has announced that its Phase III study of Cialis (tadalafil) co-administered with finasteride, has met its primary endpoint in men with lower urinary tract symptoms of benign prostatic hyperplasia (LUTS/BPH) and enlarged prostate.

Cialis 5mg once-daily, co-administered with finasteride, considerably improved scores on the International Prostate Symptom Score (IPSS), compared to placebo / finasteride at four weeks, 12 weeks and 26 weeks.

Erectile function scores, a secondary endpoint, were improved in men who had both LUTS / BPH and erectile dysfunction (ED) at baseline by Cialis / finasteride, compared to placebo / finasteride.

The University of Texas Southwestern Medical Center Department of Urology chairman Dr Claus Roehrborn said; "Symptomatic improvement with 5-ARI therapy (finasteride) is observed after six to twelve 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."

A total of 696 men aged 45 years and older, with an IPSS of minimum 13, a urine flow rate (Qmax) of 4mm per second (ml/sec) to 15ml/sec and a prostate volume at least 30ml, were assessed for 26 weeks in the double-blind study.

The Treatment Satisfaction Scale-Benign Prostatic Hyperplasia (TSS-BPH) improved with Cialis / finasteride, compared to placebo / finasteride at 26 weeks, driven by satisfaction with efficacy, with no significant difference for dosing or side effects.

Cialis, a phosphodiesterase type 5 inhibitor, was approved by the US Food and Drug Administration (FDA) for the signs and symptoms of BPH and both ED and the signs and symptoms of BPH (ED+BPH).

Finasteride, a type II 5alpha-reductase inhibitor (5-ARI), is cleared by the FDA for BPH in men with an enlarged prostate.


Image: Eli Lilly's Phase III study is the first to report on co-administration of Cialis and finasteride in men with LUTS/BPH. Photo: Courtesy of Guanaco152003.