Simenafil shows potential as erectile dysfunction treatment

The selective phosphodiesterase-5 inhibitor (PDE5i) simenafil demonstrates efficacy and good tolerability among men suffering from erectile dysfunction (ED), reports a phase II study.

A total of 255 men aged ≥22 years with a history of ED of 3 months or more were randomly allocated to receive either simenafil at fixed doses of 5, 10, and 20 mg or placebo for 8 weeks.

The primary endpoints were least square mean (LSM) changes from baseline to week 8 in the erectile function (EF) domain of the International Index of Erectile Function (IIEF) and percentages of “yes” responses to Sexual Encounter Profile (SEP) diary questions 2 (Were you able to insert your penis into your partner’s vagina?) and 3 (Did your erection last long enough for you to have successful intercourse?).

At 8 weeks, IIEF-EF scores were significantly higher with simenafil 5-, 10-, and 20-mg dose groups compared with placebo (9.7, 9.2, and 9.5 vs 5.5; p<0.001), as were the percentage of “yes” response to SEP question 2 (36.11 percent, 30.79 percent, and 33.12 percent vs 19.56 percent; p<0.01) and SEP question 3 (55.96 percent, 51.14 percent, and 51.05 percent vs 31.02 percent; p<0.001).

Adverse drug reactions occurred in 44.3 percent, 45.9 percent, and 61.7 percent of patients in the 5-, 10-, and 20-mg simenafil groups and in 36.5 percent of those in the placebo group. Overall, adverse events were either mild or moderate in severity.

“Simenafil could effectively improve erectile function, and the adverse reaction profile of simenafil was consistent with its pharmacological mechanism, with most adverse reactions being mild to moderate,” the researchers said. “The results provide a rationale for further evaluation in larger and longer-term phase III clinical trials.”