Acerus Provides Update On Avanafil Health Canada Submission
Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF) (“Acerus” or the “Company”) today announced that Health Canada has completed the initial screening process for the previously announced New Drug Submission (“NDS”) for avanafil. The dossier is now in active review by Health Canada and Acerus expects review completion and, if approved, Notice of Compliance issuance to be in early Q2 of 2020.Avanafil powder
Avanafil, a treatment for erectile dysfunction (“ED”), is a new, second generation PDE5 inhibitor, which has increased receptor specificity for fast onset of action and lower off-target side effects.
“We are pleased to report that avanafil is under active review by Health Canada. If approved, avanafil will become a key growth driver of our Canadian men’s health franchise alongside NATESTO®,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “The product is complementary to the current call point of our Canadian sales team and will allow Acerus to leverage our commercial investment in Canada.
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 (IIEF). Avanafil treatment produced statistically significant increases in vaginal penetration (up to 77%, p<0.01) and successful intercourse (up to 57%, p<0.01). In a trial examining the time-to-onset, avanafil significantly increased the proportion of subjects with successful intercourse as early as 15 minutes and at 6 hours.
Avanafil is available in the U.S. under the brand name STENDRA® (avanafil) and is indicated for the treatment of erectile dysfunction. Metuchen Pharmaceuticals LLC (“Metuchen”) has exclusive marketing rights to STENDRA® in the U.S. Acerus licensed avanafil from Metuchen for distribution in Canada.