FDA approves Cialis for enlarged prostate

October 7, 2011

The U.S. Food and Drug Administration has approved use of Eli Lilly and Co.'s Cialis medication to treat benign prostatic hyperplasia, or enlarged prostate, the Indianapolis drugmaker announced Friday morning.

Cialis, Lilly’s blockbuster erectile dysfunction drug, overtook Pfizer Inc.’s Viagra earlier this year in share of the global market for ED drugs. Cialis sales totaled $1.7 billion last year, an increase of 9 percent over the previous year.
Many men who suffer from ED also experience symptoms of enlarged prostrate. FDA approval means they now can take one medication to treat both disorders.

Lilly received the go-ahead from the FDA following positive clinical trials that included nearly 2,000 men. Exactly how Cialis reduces enlarged prostate symptoms, however, has not been established, Lilly said.

About half of men in their 60s are thought to have some symptoms of enlarged prostate.

Lilly still warns that men taking Cialis, even for enlarged prostate, shouldn’t take it in combination with alpha blockers such as Flomax because the drugs together can lower blood pressure.


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