San Diego based Apricus Biosciences, Inc. announced that its marketing application for Vitaros, indicated for the treatment of patients with Erectile Dysfunction (ED), has been accepted for review through the European Decentralized Procedure (DCP).

In connection with the DCP, on April 28, 2011, the company filed its application for marketing approval in multiple European countries, with the Netherlands serving as its Reference Member State (RMS). The RMS evaluated the application and has found it acceptable for review by the Company's chosen European Union countries for their individual consideration and approval. The DCP process takes approximately 240 days from the time of acceptance for review to final approval, and if approved, would give Apricus Bio the right to sell Vitaros as a treatment for ED in multiple chosen countries within the European Union.

“We are very pleased that our marketing application for Vitaros for ED has been accepted for review, as it speaks to the quality of the trials and clinical responses and is consistent with the guidance we received prior to filing,” said Bassam Damaj, PhD, chairman, president and chief executive officer of Apricus. “We look forward to working with the European regulatory authorities in order to make Vitaros available in Europe. In tandem, we are in the process of preparing a submission for Vitaros for ED in Switzerland, in the near future. In addition, we are actively working with our current partner in Italy and with other potential European partners on the commercialization of the product in this region.”

Vitaros is approved in Canada for the treatment of ED. The company's current plan is for commercial launch of the product in that country during the second half of 2011.

Apricus Bio, a revenue-generating pharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.