Third ED therapy given FDA approval
Cialis (tadalafil), a new oral PDE5 inhibitor for the treatment of erectile dysfunction (ED) from Lilly ICOS, has been approved by the US FDA. The new drug was shown to improve erectile function compared with placebo up to 36 hours following dosing. In clinical studies, the ability to have sexual activity was improved in some patients at 30 minutes after taking a dose.
Cialis (tadalafil), a new oral PDE5 inhibitor for the treatment of erectile dysfunction (ED) from Lilly ICOS, has been approved by the US FDA. The new drug was shown to improve erectile function compared with placebo up to 36 hours following dosing. In clinical studies, the ability to have sexual activity was improved in some patients at 30 minutes after taking a dose.
The safety and efficacy of Cialis was evaluated in 22 clinical trials in more than 4,000 patients. Cialis was shown to be effective in treating ED in patients 27 to 87 years old, including patients with other underlying medical conditions. In two of these trials, men had ED associated with diabetes or following radical prostatectomy for prostate cancer.
'Cialis is now available in approximately 50 countries and has been used by more than one million men worldwide,' said Paul Clark, ICOS chairman and chief executive officer. 'The early success of Cialis in other markets makes us confident that American men and their partners will appreciate this new treatment option.' Lilly ICOS, a joint venture between ICOS Corporation and Eli Lilly and Company, was formed to develop and market Cialis.