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FDA Approves Addition to Cialis (Tadalafil) Label

New phase IIIb data show efficacy in combination with finasteride (October 25)

The FDA has approved an addition to the product label for Cialis (tadalafil, Eli Lilly) to include data from a 26-week phase IIIb study in which once-daily tadalafil 5 mg started in combination with finasteride significantly improved the signs and symptoms of benign prostatic hyperplasia (BPH) as early as 4 weeks after treatment initiation, compared with placebo plus finasteride, in men with BPH and an enlarged prostate.

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

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

The phase IIIb, randomized, double-blind, placebo-controlled, 26-week trial assessed the efficacy and safety of once-daily tadalafil 5 mg or placebo co-administered with finasteride 5 mg in 696 men aged 45 years and older (mean age, 64 years) with an International Prostate Symptom Score (IPSS) of at least 13, a urine flow rate (Qmax) of 4 to 15 mL/sec, and a prostate volume of at least 30 mL.

The study‚Äôs primary endpoint — changes in the total IPSS at 12 weeks — demonstrated that symptom improvement in patients starting BPH treatment with once-daily tadalafil 5 mg and finasteride was significantly greater than that in subjects starting treatment with placebo and finasteride (–5.2 vs. –3.8, respectively; P = 0.001). Key secondary endpoints demonstrated that improvements in IPSS occurred at the first scheduled observation at week 4 (–4.0 vs. –2.3; P < 0.001) and continued through week 26.

In a subgroup of patients with BPH who were also sexually active and had ED at baseline, tadalafil initiated with finasteride significantly improved erectile function, as measured by the International Index of Erectile Dysfunction — Erectile Function Domain, compared with placebo and finasteride. These results were evident at 4 weeks (+3.7 vs. –1.1, respectively; P < 0.001), at 12 weeks (+4.7 vs. +0.6; P < 0.001), and at 26 weeks (+4.7 vs. 0.0; P < 0.001).

The results from this study have been accepted for publication in the Journal of Urology and are available online.

Source: Eli Lilly; October 24, 2013.

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