FDA Approves Addition to Cialis Labeling

CIALIS (tadalafil) tablets
CIALIS (tadalafil) tablets

Eli Lilly announced that the FDA has approved an addition to the Cialis (tadalafil) label to include data from a 26-week study that showed Cialis 5mg once daily started in combination with finasteride significantly improved the signs and symptoms of benign prostatic hyperplasia (BPH) as early as 4 weeks.

RELATED: Urological Disorders Resource Center

Cialis is a phosphodiesterase type 5 inhibitor (cGMP-specific) indicated to treat erectile dysfunction (ED), the signs and symptoms of BPH, and both ED and the signs and symptoms of BPH. Finasteride is a type II 5 alpha-reductase inhibitor approved for the treatment of BPH in men with an enlarged prostate.

The approved clinical data is from a Phase 3b, randomized, double-blind, placebo-controlled, 26-week trial that assessed the efficacy and safety of Cialis 5mg for once-daily use or placebo administered with finasteride 5mg in 696 men aged >45 years. 

Enrolled patients had an International Prostate Symptom Score (IPSS) >13, a urine flow rate (Qmax) of 4–15mL/sec, and a prostate volume at >30mL. IPSS is a questionnaire evaluating lower urinary tract symptoms occurring during the preceding month.

The primary endpoint of the study  was  the change in total International IPSS at 12 weeks . Results showed that symptom improvement in patients starting BPH treatment with Cialis 5mg once-daily with finasteride was greater than those starting with placebo and finasteride (-5.2 vs. -3.8; P=0.001).

The initial combination therapy is recommended for up to 26 weeks because the incremental benefit of Cialis decreases from 4 weeks until 26 weeks, and the incremental benefit of Cialis beyond 26 weeks is unknown.

For more information call (800) 654-2452 or read more about this Phase 3b study

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