AcelRx Pharma Offers Updates on Clinical Trials

AcelRx Pharmaceuticals, Inc.

, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced continuing progress on its two remaining Phase 3 trials of the Sufentanil NanoTab PCA System being studied in post-operative pain.  The first of those studies in patients after major abdominal surgery completed the last patient earlier this quarter, and is expected to provide data later this quarter.  The second study, in patients after major orthopedic surgery, continues to enroll patients, with the last patient expected to enroll around the end of the first quarter of 2013, and data expected in the second quarter.  A New Drug Application (NDA) submission for the NanoTab System remains on track for the third quarter of 2013.  In addition, a Phase 2 clinical trial with ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, has completed dosing and results from this study are expected to be available in the second quarter of 2013. "We look forward to sharing the top-line results from our abdominal surgery pain study with our lead product candidate, the Sufentanil NanoTab PCA System, later this quarter and remain on track for an NDA submission later this year," said Richard King, president and chief executive officer of AcelRx.     Status of Ongoing Clinical Trials o The last patient has completed the Sufentanil NanoTab PCA System Phase 3 double-blind, placebo-controlled post-operative pain study conducted in patients following open abdominal surgery.  The study, initiated in March 2012, enrolled 178 patients at 14 sites. The study is designed to assess the ability of sufentanil, delivered through the NanoTab System to control moderate-to-severe post-operative pain over 48 to 72 hours compared to a placebo delivered through the NanoTab System.  The study will also assess the tolerability, safety, and ease of use of the NanoTab System by nurses and patients.  Top-line results are expected in the first quarter of 2013.  o A second placebo-controlled Phase 3 trial with the Sufentanil NanoTab PCA System is being conducted at approximately 32 sites in patients following hip or knee replacement surgery.   Targeting enrollment of approximately 400 patients, dosing of the final subject in this study is expected around the end of the first quarter of 2013.  The primary endpoint for both the abdominal and orthopedic placebo-controlled Phase 3 studies is the sum of pain intensity difference to baseline (SPID) over 48 hours. Top-line results should be available for the orthopedic study during the second quarter of 2013. o Dosing of the last patient in a Phase 2, placebo-controlled, dose-finding study of the Company's ARX-04 sufentanil NanoTab product has completed.  This study, which began in November 2012, enrolled 101 patients following bunionectomy surgery, randomized into one of three groups: 20 mcg sufentanil NanoTab, 30 mcg sufentanil NanoTab or placebo.  Each dose was administered by healthcare personnel, as requested by the patient, up to a maximum of one dose every hour.  The study is designed to evaluate the ability of sufentanil NanoTabs to manage moderate-to-severe acute pain over the first 12 hours following bunionectomy surgery.  ARX-04 is a sublingual sufentanil product candidate designed to provide a non-invasive, fast-onset treatment of patients with moderate-to-sever acute pain, both on the battlefield and in civilian settings of trauma or injury.  AcelRx is conducting the study at two sites with funding provided by a $5.6 million grant from the U.S. Army Medical Research and Materiel Command (USAMRMC).  Top-line results from the trial are expected during the second quarter of 2013.