Apricus Bio said that Vitaros incorporates alprostadil, a well-recognised vasodilator that is currently marketed as an injectable product or an intra-urethral insert product for patients with erectile dysfunction.
Apricus Bio incorporated its proprietary NexACT drug delivery technology in the development of Vitaros as a patient-friendly topically-applied treatment for erectile dysfunction.
Apricus Bio president and CEO Bassam Damaj said that they were thrilled to have received the approval from Health Canada.
"Data from our clinical trials showed that patients responded to treatment within minutes of applying Vitaros," Damaj said.
"We view this Canadian approval as a validation of the NexACT technology as a transdermal delivery mechanism that is safe and effective.
"In addition, we will use this approval as the basis for seeking registration of the product for marketing in over 100 international markets."