AcelRx Receives Notice of Eligibility for Centralized Review from European Medicines Agency for the Sufentanil NanoTab PCA System
AcelRx Pharmaceuticals (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced a decision by the European Medicines Agency, or EMA, to permit registration of the Sufentanil NanoTab PCA System (ARX-01) via the centralized procedure under Article 3(2) (b) of Regulation EC 726/2004. This procedure will allow AcelRx to submit a single Marketing Authorization Application, or MAA, to the EMA for approval to market ARX-01 in all 27 European Union, or EU, member states, as well as in the 4 European Free Trade Association, or EFTA, countries, through a single evaluation that will be carried out through the Committee for Medicinal Products for Human Use. The 31 EU / EFTA countries represent a population of over 500 million people, with more than 20 million patients undergoing surgery each year resulting in moderate to severe pain in the days after surgery.
ARX-01 is a novel, non-invasive, sublingual patient-controlled analgesia (PCA) system currently in three Phase 3 clinical trials for the treatment of