FDA approves tadalafil to treat benign prostatic hyperplasia

October 7, 2011

FDA has approved tadalafil (Cialis, Eli Lilly) for 3 indications: ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions.

FDA has approved tadalafil (Cialis, Eli Lilly) tablets for once-daily use for the treatment of men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH). FDA also approved tadalafil for once-daily use for a separate indication for the treatment of the signs and symptoms of BPH.

This means that tadalafil is now approved for 3 indications: ED, the signs and symptoms of BPH, and ED and the signs and symptoms of BPH in men who have both conditions.

The new indications for once-daily use of tadalafil are based on a clinical trial program of 3 placebo-controlled efficacy and safety studies that included 1,989 men. Two of these studies were of men with BPH, and 1 study was specific to men with both ED and BPH. In the ED+BPH study, Cialis 5 mg for once daily use significantly improved scores on the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), a questionnaire evaluating sexual function, and the International Prostate Symptom Score (IPSS), a questionnaire evaluating symptoms of BPH.

Tadalafil should not be taken with "nitrates" (often prescribed for chest pain); or with recreational drugs known as "poppers," such as amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure; or if the patient is allergic to Cialis or Adcirca (tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash or hives, should call a healthcare provider.

"Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians," said Claus Roehrborn, MD, chairman, department of urology, The University of Texas Southwestern Medical Center.

Tadalafil inhibits an enzyme called phosphodiesterase type 5 (PDE5). By inhibiting PDE5 in the penis, tadalafil helps produce vascular relaxation and increases blood flow. PDE5 enzymes are also found in the prostate and bladder. The mechanism for how tadalafil reduces BPH symptoms has not been established.

FDA has approved 8 other drugs to treat symptoms of BPH: finasteride (Proscar, Merck), dutasteride (Avodart, GlaxoSmithKline), dutasteride plus tamsulosin (Jalyn, GlaxoSmithKline), and the alpha blockers: terazosin (Hytrin, Abbott Laboratories), doxazosin (Cardura, Pfizer Labs), tamsulosin (Flomax, Boehringer Ingelheim), alfuzosin (Uroxatral, Sanofi-Aventis), and silodosin (Rapaflo, Watson).