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| |  CUA: CIALIS (IC351) Restores Natural Sexual Function For 24-Hour Period TORONTO, ON -- June 25, 2001 -- IC351 (proposed brand name Cialis™), a new oral medication currently under investigation for the treatment of erectile dysfunction (ED), enables men to have intercourse whenever they want - for up to 24 hours after taking the drug. As with any natural sexual experience, IC351 works only following sexual stimulation. IC351 also takes effect in as little as 16 minutes and has demonstrated improved erections in 88 percent of men. These data will be presented at the Canadian Urological Association (CUA) meeting being held in Toronto this week. "Cialis has important potential for men with ED," said Dr. Gerald Brock, a urologist from St. Joseph's Health Centre in London, Ontario, and a IC351 investigator. "In clinical trials, Cialis enables men to engage in sexual intercourse multiple times over a 24-hour period, permitting couples to regain spontaneity in their sexual relationship." In the first of two Phase III trials to measure responsiveness, 61 men with mild-to-severe ED received IC351 10 mg or placebo. After taking IC351, men underwent an evaluation for firmness and duration of erections while being exposed to visual sexual stimulation. Men in the IC351 group were significantly more successful in achieving erections than men in the placebo group, even when evaluated at 24 hours after taking the treatment. In a home-based study, 223 men received IC351 (up to 20 mg) or placebo to measure the time it takes to get an erection. The men were instructed to take the medication when they and their partners desired to engage in sexual activity, and to use a stopwatch to record the elapsed time until they achieved an erection sufficient for successful intercourse. In this trial, the ability to achieve an erection after sexual stimulation was statistically superior in the group taking IC351 as compared with the placebo group at 16 minutes post-dosing. Patients on IC351 in this study also recorded more success at second sexual encounters for a period of up to 24 hours after the drug took effect. Canadian Phase II data shows that up to 88 percent of men taking IC351 for ED reported improved erections relative to placebo. These findings show that IC351 increased the percentage of successful and satisfying intercourse attempts for both men and their partners. Clinical research has demonstrated good tolerability over the entire duration of the medication’s effect, with headache and dyspepsia (upset stomach) the most commonly reported side effects. These events were generally considered mild-to-moderate and tended to diminish with continued treatment. "Individuals involved in the clinical trials have been very pleased with IC351, particularly because of the product's minimal side effects," stated Dr. Brock. "The 24-hour duration of responsiveness does not appear to alter this situation and simply allows men to benefit from this important treatment feature." Erectile dysfunction is defined as the consistent inability to attain and maintain an erection sufficient for sexual intercourse. It affects an estimated 152 million men and their partners worldwide with many cases caused by physical conditions, including cardiovascular disease and diabetes. SOURCE: Eli Lilly Canada Inc.
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