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GEN News Highlights : Oct 7, 2011

FDA Clears Lilly’s Cialis for Treating Symptoms of BPH in Men with or without Erectile Dysfunction

Studies showed drug significantly improved scores of sexual function and symptoms of BPH.

FDA  approved Eli Lilly’s Cialis® as a once-daily treatment for men with both erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH). It also granted separate approval for once-daily use in treating the signs and symptoms of BPH alone. The drug was previously marketed for the treatment of erectile dysfunction.

Clearance for the two new indications was based on three placebo-controlled efficacy and safety studies conducted in just under 2,000 men: two of these studies were in men with BPH and one specific to men with both ED and BPH. In the ED+BPH trial, Cialis 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).

Cialis is a phosphodiesterase type 5 (PDE5) inhibitor that  results in vascular relaxation and increased blood flow to the penis. The drug is contraindicated for use in patients who are also taking nitrates due to a combined effect on lowering blood pressure.

Cialis was first approved In Europe in 2002 and in the U.S. in 2004 for the treatment of ED. The drug achieved sales of $477 million in the second quarter of 2011, up 14% on the equivalent period in 2010. Sales of the drug for the first half of 2011 were $911.6 million, up 10% on 2010.

FDA notes that there are currently eight other drugs approved to treat the symptoms of BPH: Proscare (Merck & Co.), Avodart and Jalyn (GlaxoSmithKline), Hytrin (terazosin), Cardura (Pfizer), Flomax (Boehring Ingelheim), Uroxatral (Sanofi), and Rapaflo (Watson Pharmaceuticals).