AcelRx commences third ARX-01 Phase 3 study in post-operative pain

AcelRx Pharmaceuticals, Inc. (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 dosing of the first patient in the third of three planned Phase 3 studies for ARX-01, the Sufentanil NanoTab PCA System, its novel sublingual patient-controlled analgesia (PCA) system.  This third ARX-01 Phase 3 study is a randomized, double-blind, placebo controlled efficacy and safety trial in adults following hip or knee replacement surgery.

"The start of our third Phase 3 clinical trial for ARX-01 is an important milestone for our lead Sufentanil NanoTab development program," said Richard King, AcelRx's president and CEO.  "The results of all three Phase 3 registration studies are expected to form the basis of a New Drug Application for ARX-01, which we plan to submit to the FDA during the third quarter of 2013.  The ARX-01 System is designed to provide an attractive post-operative pain treatment alternative compared to the current standard of care that utilizes intravenous pumps primarily delivering morphine."

This third study is designed to enroll approximately 400 patients, randomized 3:1 to receive 15 mcg Sufentanil NanoTabs or placebo NanoTabs.  Both treatments are being delivered via the ARX-01 system at a maximum dosing rate of one NanoTab every 20 minutes to control pain.  Patients will be followed for a minimum of 48 hours and, as needed, up to 72 hours after randomization.  The study will be conducted at approximately 45 academic and community hospitals in the U.S.  The primary endpoint is the sum of the pain intensity difference to baseline, over the 48 hour study period, or SPID-48, which is the FDA standard for post-operative acute pain studies.  Secondary endpoints include pain relief scores, patient global satisfaction ratings, and use of rescue medication.  The ease of set up and operation of the ARX-01 system for nursing staff and patients, respectively, will also be measured through questionnaires.  Topline results for the third Phase 3 clinical study are expected to be available during the first quarter of 2013.  

In March 2012, AcelRx began its first Phase 3 clinical study for ARX-01, a randomized, double-blind, placebo-controlled efficacy and safety study for post-operative pain following major open abdominal surgery designed to enroll 150 patients.  The primary endpoint for this study is SPID-48.  In April 2012, the second Phase 3 clinical study for ARX-01 began.  It is a randomized, multicenter, open-label, parallel group design that compares the efficacy and safety of the Sufentanil NanoTab PCA System to the standard of care, IV PCA with morphine, in the treatment of post-operative pain associated with major abdominal or orthopedic surgeries.  The primary objective of the study, which is expected to enroll approximately 400 patients, is to compare ARX-01 to IV PCA with morphine in terms of patient global satisfaction with the method of pain relief.  Patients in each of these two studies will be treated for a minimum of 48 hours after randomization and topline results for both clinical trials are expected during the fourth quarter of 2012.