The FINANCIAL -- INDIANAPOLIS, Oct. 7, 2011 -- Eli Lilly and Company announced today that
the U.S. Food and Drug Administration (FDA) has approved Cialis®
(tadalafil) 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).
The FDA also approved Cialis for once daily use for a separate indication for the treatment of the signs and symptoms of BPH. This means Cialis is now approved for three 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 Cialis for once daily use are based on a clinical trial program of three placebo-controlled efficacy and safety studies that included 1,989 men. Two of these studies were in men with BPH, and one 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.
It is important to note that Cialis is not to be taken with medicines called "nitrates" (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 or hives, should call a healthcare provider or get help right away.
"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. "The FDA approval of Cialis for once daily use for the treatment of ED and the signs and symptoms of BPH provides a new option that allows men to treat both with one daily medication."
Cialis inhibits an enzyme called phosphodiesterase type 5 (PDE5). By inhibiting PDE5 in the penis, Cialis helps produce vascular relaxation and increases blood flow. PDE5 enzymes are also found in the prostate and bladder. The mechanism for how Cialis reduces BPH symptoms has not been established.
"These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health," said Dave Ricks, Lilly USA President. "We're encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH."
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