Apricus Biosciences gains two more approvals for ED drug Vitaros

USA-based Apricus Biosciences (Nasdaq: APRI) says that the Irish Medicines Board and the Netherlands' Medicines Evaluations Board have each granted national phase approvals to Vitaros (alprostadil), indicated for the treatment of patients with erectile dysfunction (ED).

The company has now received a total of four national phase approvals for Vitaros. with the latest two adding to Sweden and the UK.

In June 2013, Apricus announced that its marketing application for Vitaros was approved through the European Decentralized Procedure. Under the DCP, Apricus filed its application for marketing approval designating Netherlands as the Reference Member State on behalf of nine other European Concerned Member States (CMS) participating in the procedure. The company continues to work independently, as well as with its commercialization partners, to obtain country-by-country national phase approvals in the remaining CMS territories including France, Germany, Italy, Spain, Belgium and Luxembourg. Once the national phase approvals are secured on a country-by-country basis, marketing of Vitaros can then be initiated in each country by Apricus' commercialization partners.