AcelRx initiates ARX-01 Phase 3 study for treatment of post-operative pain

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), ("AcelRx"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, reported dosing of the first patient in a Phase 3 study for ARX-01, the Sufentanil NanoTab PCA System, its novel sublingual patient-controlled analgesia system. This first ARX-01 Phase 3 study is a randomized, double-blind, placebo-controlled efficacy and safety trial in adults following open abdominal surgery.  Approximately 150 adults, randomized 2:1 to active or placebo groups, will be treated for post-operative pain for a minimum of 48 hours and, as needed, up to 72 hours after randomization.  The study will be conducted at 12 academic and community hospitals in the United States.

The remainder of the planned Phase 3 clinical program for ARX-01 includes a second randomized, double-blind, placebo-controlled efficacy and safety study comparing Sufentanil NanoTabs to placebo for post-operative pain control following major joint replacement surgery, and an open-label active-comparator study comparing ARX-01 to the current standard of care, intravenous patient-controlled analgesia, or IV PCA, with morphine.

"We are extremely pleased to have our ARX-01 Phase 3 clinical program underway.  This year is an exciting time for AcelRx, with the delivery of top-line data from all three Phase 3 clinical trials expected by late 2012 or early 2013," said Richard King, AcelRx's Chief Executive Officer.  Mr. King added, "We hope to be in a position to file an NDA with the FDA in mid-2013 for ARX-01.  We believe ARX-01 is highly differentiated from the current standard of care for post-operative pain management, IV PCA.  We look forward to the time when ARX-01 will be available to patients and health care providers as a non-invasive, pre-programmed, high therapeutic index opioid alternative to IV PCA."