The FDA has approved Eli Lilly’s Cialis (tadalafil) to treat men with signs and symptoms of Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED).
The drug works by inhibiting the phosphodiesterase type 5 enzyme (PDE5), helping to produce vascular relaxation and increase blood flow to the penis. These enzymes are also found in the prostate and bladder, where problems can occur with BPH.
Claus Roehrborn, Chairman of the Department of Urology at The University of Texas Southwestern Medical Centre, said: “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.”
The approval totals three indications: both ED and signs and symptoms of BPH separately, as well as for men who have both conditions.
Dave Ricks, Lilly USA President, said: “These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men’s health.”
“We’re encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH,” commented Mr Ricks.
The FDA clearance was based on clinical research gathered from three placebo-controlled efficacy and safety studies involved 1,989 men.
BPH is a condition where the prostate enlarges, which can cause urinary problems. Approximately 50% of men between 40-70 years old suffer from erectile dysfunction. Several studies have shown that many men with ED also experience the symptoms of BPH.