The filing of the Avanafil NDS is an important next step in solidifying our presence in men's health.
The safety and efficacy of Avanafil is supported by four randomized, double-blind, placebo-controlled, parallel trials, which included subjects with erectile dysfunction from either a general ED population, ED patients with diabetes or ED patients following bilateral nerve-sparing radical prostatectomy.
In all Phase 3 trials, statistically significant improvement in the primary efficacy measures were observed and were maintained throughout the 8-12-week treatment period.
This included statistically significant improvements of +40% to +75% in the erectile function domain of the International Index of Erectile Function.
Avanafil treatment produced statistically significant increases in vaginal penetration (up to 77%, p
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