The FINANCIAL -- INDIANAPOLIS, Oct. 12, 2011 -- Eli Lilly and Company
announced today that a pivotal Phase III study of Cialis® (tadalafil)
tablets 5 mg for once daily use met its co-primary endpoints,
significantly improving measures of both erectile dysfunction (ED) and
signs and symptoms of benign prostatic hyperplasia (BPH) in men with
both conditions.
The study is available online in The Journal of Sexual Medicine. It is one of three efficacy and safety studies included in the supplemental new drug application Lilly submitted to the U.S. Food and Drug Administration (FDA) last year seeking approval for Cialis in the treatment of the signs and symptoms of BPH and the treatment of both ED and the signs and symptoms of BPH (ED+BPH).
The FDA approved Cialis on Thursday for both new indications.
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.
"We are pleased with the outcomes of this study," said Anthony Beardsworth, M.D., senior medical director for Eli Lilly and Company. "Lilly is committed to research that can help us offer new treatment options and advance our understanding of ED and BPH, conditions that affect millions of men worldwide."
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