5 March 2019 - - Canadian-based specialty pharmaceutical company Acerus Pharmaceuticals Corp. (TSX: ASP) has filed a New Drug Submission for Avanafil with Health Canada. Avanafil, a treatment for erectile dysfunction, is a new, second generation PDE5 inhibitor, which has increased receptor specificity for fast onset of action and lower off-target side effects, the company said.

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