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FDA Approves Addition to CIALIS® (tadalafil) Product Label

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Eli Lilly and Company announced the U.S. FDA approved a product label addition for CIALIS 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.

CIALIS 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.

"Urinary symptom improvement with 5-ARI therapy can take 6 to 12 months," said Claus Roehrborn, MD, chairman, Department of Urology, The University of Texas Southwestern Medical Center. "These data demonstrate that the combination of CIALIS 5 mg for once daily use with finasteride leads to symptom improvement as early as four 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."

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 (-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.

It is important to note that CIALIS is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain; or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure; or if allergic to CIALIS or ADCIRCA® (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away.

In a subgroup of patients with BPH who were also sexually active and had ED at baseline, CIALIS 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).