Company announced today that the European Commission has approved Cialis® (tadalafil) tablets 5 mg for once a day use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
The new indication for Cialis 5 mg for once a day use is based on a clinical trial program of four clinical studies of BPH that included 1,500 men, including one study of men with both BPH and erectile dysfunction (ED).
"Cialis is the only medication approved in the EU to treat both BPH symptoms and ED," said Kraig Kinchen, M.D., senior medical director at Lilly. "Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a useful therapeutic option available for doctors."
In addition to the U.S. and EU, Cialis for once a day use has been approved to treat the signs and symptoms of BPH in Canada, Mexico, Brazil, South Korea, Russia, Panama, Argentina, Honduras, Ecuador, Costa Rica, Colombia and Israel.
The most commonly reported adverse events in patients taking Cialis for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, indigestion, back pain and muscle pain. They were transient and generally mild or moderate.
BPH is a condition where the prostate enlarges, which can cause urinary symptoms. Common symptoms of BPH include:
ED is a condition in which the penis does not fill with enough blood to harden and expand when a man is sexually stimulated, or when he cannot keep an erection. Approximately 40 percent of men over 40 have ED.[i]
BPH and ED are conditions that may occur in the same patient. Several studies have shown that many men with ED also experience the symptoms of BPH.[ii],[iii],[iv]
Tadalafil inhibits an enzyme called phosphodiesterase type 5 (PDE5). By inhibiting PDE5 in the penis, tadalafil helps produce vascular smooth muscle relaxation and increases blood flow. PDE5 enzymes are also found in the smooth muscle of the prostate and bladder. The mechanism for how tadalafil reduces BPH symptoms has not been fully established.
About Tadalafil (Cialis) Tadalafil was approved for the treatment of erectile dysfunction in the EU in 2002. Tadalafil for once a day use was approved for the treatment of erectile dysfunction in the EU in 2007.
Tadalafil is approved to treat erectile dysfunction (ED) in adult males in more than 100 countries throughout the world, including in the United States, Europe, Australia, Mexico and Canada.
There are two different dosing options: tadalafil for once a day use (2.5 and 5 mg) or tadalafil for use as-needed, or 'on-demand'(10 mg and 20 mg). Tadalafil on demand is a prescription only medicine licensed in the EU for the treatment of erectile dysfunction. Tadalafil for once a day use is a prescription ED treatment that is taken every day.Tadalafil on demand may be taken at least 30 minutes prior to sexual activity, with or without food, and may work for up to 36 hours following dosing.
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