Investigational PDE-5 inhibitor improves erectile function

February 1, 2012

Avanafil, an investigational phosphodiesterase type-5 inhibitor, appears to significantly improve erectile function with low rates of side effects, according to results from a randomized, placebo-controlled, phase III study.

Avanafil, an investigational phosphodiesterase type-5 inhibitor, appears to significantly improve erectile function with low rates of side effects, according to results from a randomized, placebo-controlled, phase III study.

Data from the REVIVE study, which were published online in The Journal of Sexual Medicine (Jan. 16, 2012), showed that patients who attempted intercourse within 15 minutes of dosing were successful 64%, 67%, and 71% of the time with 50, 100, and 200 mg of avanafil treatment, respectively, versus 27% for placebo (p

"While PDE-5 inhibitors are currently used as first-line therapy for treatment of ED in the general population, what’s new and novel about avanafil is that it has a fast onset of action and high selectivity," said lead investigator Irwin Goldstein, MD, of San Diego Sexual Medicine at Alvarado Hospital. "For patients, this means that avanafil, if approved, could be taken on-demand with potentially fewer side effects."

Following 12 weeks of treatment, without restrictions on food or alcohol, all three doses of avanafil were significantly superior to placebo for all primary endpoints (p≤.001). Nearly 80% of all sexual attempts among patients in the 200-mg dose group of avanafil had erections sufficient for intercourse.

The most common side effects were headache, flushing, nasal congestion, and back pain, with no drug-related serious adverse events reported.

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