DAILY AND ON-DEMAND IC351 TREATMENT OF ERECTILE DYSFUNCTION

Francois Giuliano, Hartmut Porst, Harin Padma-Nathan, Jay Saoud, Kenneth Ferguson, Steven Whitaker, William Pullman, Raymond Rosen Bicetre, France; Hamburg, Germany; Beverly Hills, CA; Bothell, WA; Indianapolis, IN; Piscataway, NJ

INTRODUCTION AND OBJECTIVES: IC351 is a selective inhibitor of phosphodiesterase type 5. Two double-blind, placebo (PB)-controlled studies assessed the safety and efficacy of daily and on-demand IC351 treatment (Rx) in men with erectile dysfunction (ED).

METHODS: Following a 3-wk, Rx-free run-in period, men were randomized to 3 wks daily Rx with PB or IC351 (up to 100 mg), or on-demand Rx with PB or IC351 (up to 25 mg). Baseline International Index of Erectile Function (IIEF) scores and sexual encounter profile (SEP) diary data were collected during the run-in period for comparison with scores and data collected during the Rx period. Primary endpoints were change from baseline in questions 3 (Q3) and 4 (Q4) of the IIEF. Secondary endpoints included change from baseline in all IIEF domains and in SEP responses.

RESULTS: Compared with PB, IC351 significantly improved erectile function as assessed by all study endpoints. In the IC351 groups, the change in IIEF Q3 ranged from 1.33-1.66 (p0.001 compared with PB) with daily Rx and from 0.61-1.32 (p0.001 compared with PB) with on-demand Rx. The change in Q4 ranged from 1.79-2.10 (p0.001 compared with PB) with daily Rx and from 0.78-1.70 (p0.001 compared with PB) with on-demand Rx. Successful intercourse rates on IC351, as reported in SEP mdiaries, were up to 93% with daily therapy and 70% with on-demand therapy. Adverse events were dose-related, more common in patients receiving daily IC351, and attenuated with continued Rx. The most common adverse events were headache, back pain, myalgia, and dyspepsia. Rx-related headache (the most common adverse event) was observed in 13-46% of patients receiving daily IC351 (PB, 3%), and in 3-17% of patients receiving IC351 on demand (PB, 6%). There were no Rx-related changes in vital signs, ECG, or laboratory measures.

CONCLUSIONS: In these studies, IC351 significantly enhanced erectile function and was safe and well tolerated.

Supported by: ICOS Corporation