Site About Cialis Pills.

Lilly ICOS LLC announced today that the European Commission has granted a marketing authorization for Cialis(TM) (tadalafil), an oral PDE5 inhibitor for the treatment of impotence for all 15-member states of the European Union. The approval decision follows a positive opinion adopted July 25, 2002, by the European Committee for Proprietary Medicinal Products (CPMP). Lilly ICOS anticipates launching Cialis in Europe during the first half of 2003.

The European Commission based its decision on the review and evaluation of the comprehensive data package of Cialis that comprised results of more than 60 studies in more than 4,000 people to characterize the safety and efficacy profile of Cialis. The randomised, placebo-controlled, Phase 3 primary efficacy studies of Cialis involved 1,112 men (804 Cialis, 308 placebo) with impotence of various causes and severity and evaluated doses including 10 and 20 mg.

“Not only is the approval of Cialis a significant milestone for Lilly ICOS, but we believe it is an important step forward for millions of men in Europe who suffer from impotence,” said Paul Clark, ICOS chairman and chief executive officer.

“Cialis will provide an important new treatment option for many of the 31 million men in Europe with impotence,” said Richard Pilnik, president of European operations for Lilly.

About Impotence:

Impotence is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. Impotence affects an estimated 152 million men and their partners worldwide(1). Up to 80 percent of impotence cases are caused by physiological conditions, including cardiovascular disease and diabetes, with psychological factors accounting for the remaining 20 percent. In many cases, however, both psychological and physical factors contribute to the condition.

The drug is being developed in the US, impotent men who take a new drug for the condition may be able to have sex up to 34 hours later, claims the maker Cialis, a medication trying to gain a foothold in the lucrative anti-impotence market created by Viagra, is being tested by doctors.

Pharmaceutical firm Eli Lilly wants to be able to market Cialis in the US from the second half of this year. Their trial involved 223 men with moderate to severe impotence, some of whom were given Cialis, and the rest a dummy placebo. While the drug group were statistically more likely to achieve erection, they were also more likely to have successful second sexual encounters during a 24-hour period.

Dr Harin Padma-Nathan, a professor of urology at the University of Southern California, who led the study, acknowledged that other impotence drugs had not been tested for this longevity of effect. However, he said: “We saw a huge clinical difference within 36 hours in patients taking Cialis and many of the men indicated a sense of freedom and spontaneity.”

According to newly released clinical data on Cialis(TM), an investigational PDE5 inhibitor being developed by Lilly ICOS LLC for the treatment of erectile dysfunction (ED), men with ED reported a statistically significant improvement in successful intercourse attempts at 24 and 36 hours after taking the drug, compared to placebo.

These and other new findings - including a summary of cardiovascular safety data that showed no increased incidence of cardiovascular events during clinical studies - are being presented at the 97th Annual Meeting of the American Urological Association.

Cialis Period of Effectiveness - Key Study Findings:

In a Phase III clinical study designed to evaluate the efficacy of Cialis at specific time points after dosing, 1348 men with mild-to-severe ED were randomly assigned to receive Cialis 20 mg (n=175) or placebo (n=173) over approximately an eight-week period. Patients were instructed to attempt intercourse with their partners on four specific occasions: on two occasions at 24 hours after dosing and on two occasions at 36 hours after dosing. The primary endpoint was the percentage of successful sexual intercourse attempts.