FDA approves label addition for PDE-5 inhibitor

The FDA has approved a product label addition for the phosphodiesterase-type-5 inhibitor tadalafil (Cialis) that involves its use with finasteride (Proscar).

The addition includes data from a 26-week study that showed tadalafil, 5 mg for once-daily use, started in combination with finasteride significantly improved the signs and symptoms of BPH as early as 4 weeks, compared to placebo with 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 the incremental benefit of tadalafil beyond 26 weeks is unknown, according to Eli Lilly and Co., which makes tadalafil.

Tadalafil is approved by the FDA to treat erectile dysfunction, the signs and symptoms of BPH, and both ED and the signs and symptoms of BPH (ED+BPH).

"Urinary symptom improvement with 5-ARI therapy can take 6 to 12 months. These data demonstrate that the combination of Cialis 5 mg for once-daily use with finasteride leads to symptom improvement as early as 4 weeks in men with BPH and an enlarged prostate. This means that Cialis 5 mg for once-daily use can be an effective option for early symptom relief when started in combination with finasteride," said Claus Roehrborn, MD, of the University of Texas Southwestern Medical Center, Dallas.

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 tadalafil, 5 mg for once-daily use, and finasteride was greater than in those starting with placebo and finasteride (–5.2 vs. –3.8; p=.001). Key secondary endpoints demonstrated that improvements in IPSS occurred at the first scheduled observation at week 4 (–4.0 vs. –2.3; p<.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 to placebo with finasteride. These results were evident at 4 weeks (3.7 vs. –1.1; p<.001), 12 weeks (4.7 vs. 0.6; p<.001), and 26 weeks (4.7 vs. 0.0; p<.001).

Dr. Roehrborn is a consultant/adviser for Eli Lilly and Co.

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