First Phase III data on Lilly ICOS LLC's IC351 in hard-to-treat patients

Cialis (IC351), the phosphodiesterase-5 inhibitor for male erectiledysfunction being developed by Eli Lilly and ICOS' joint venture Lilly ICOS LLC, has been shown to be effective in diabetes-related ED, a notoriously hard-to-treat condition. The results come from the first Phase III trial of the drug, presented at the European Association of Urology meeting in Geneva, Switzerland, and show that on-demand treatment with Cialis 20mg led to improved erections in 64% of men treated with the drug.

ED secondary to diabetes tends to be very hard to treat due to the impairment in nerve and blood vessel function characteristic of the disease. In this Phase III trial, 216 men with mild-to-severe diabetes-related ED were randomized to receive either Cialis at doses up to 20mg or placebo for 12 weeks. Cialis' 64% success rate compares favorably with both the placebo response (25%) and historical data from studies of other ED treatments in this setting and, importantly, was seen regardless of the patient's age and the duration and severity of the dysfunction.

Headache and dyspepsia were the only side effects reported by more than 5% of all Cialis-treated participants, and there were no cases of disturbances in color vision, which are a recognized side effect with Pfizer's Viagra (sildenafil), the first and only PDE-5 inhibitor on the market for ED (Marketletters passim). Lilly notes that researchers observed no significant changes in electrocardiograms or blood pressure in this trial which, along with the lack of ocular effects, bodes well for Cialis' selectivity for its target erectile tissue.