Positive Ph III results for VIVUS' avanafil in diabetics with erectile dysfunction

California, USA-based VIVUS announced positive results from the Phase III REVIVE-Diabetes (TA-302) study, evaluating the safety and efficacy of its investigational drug avanafil for the treatment of erectile dysfunction (ED) in men with type 1 and type 2 diabetes. The news lifted the firm's share price, which has more than doubled over the past 12 months, a further 2.4% to $12.61 in morning trading yesterday.

The REVIVE-Diabetes study met all three primary endpoints across the two doses studied by demonstrating statistically-significant improvement in erectile function as measured by the Sexual Encounter Profile (SEP) and improvements in the International Index of Erectile Function (IIEF) score. The study also demonstrated a favorable side effect profile and successful intercourse (as measured by SEP 3) in as little as 15 minutes and beyond six hours after dosing, without any restrictions for food or alcohol intake.

These results follow the avanafil data presentation at the American Urological Association (AUA) 2010 annual meeting last week, highlighting positive results from the company's first pivotal Phase III study of avanafil evaluating treatment in men with a history of general ED.