FDA announces label addition to Cialis (Eli Lilly) for BPH

The FDA has approved a product label addition for Cialis (tadalafil), from Eli Lilly, to include data from a 26-week study that showed Cialis 5 mg for once daily use started in combination with finasteride significantly improved the signs and symptoms of Benign Prostatic Hyperplasia (BPH) as early as 4 weeks, compared to placebo with finasteride, in men with BPH and an enlarged prostate. The combination of Cialis and finasteride initiated for BPH 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.

The primary endpoint of the study - changes in total International Prostate Symptom Score (IPSS) at 12 weeks - demonstrated that symptom improvement in patients starting BPH treatment with Cialis 5 mg for once daily use and finasteride was greater than those starting with placebo and finasteride. Key secondary endpoints demonstrated that improvements in IPSS occurred at the first scheduled observation at week 4 and continued through week 26.