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.About Post-Operative Pain Acute pain management in the hospital, in particular post-operative analgesia, remains a challenge for healthcare providers with up to 75% of patients reporting inadequate pain relief after surgery. Inadequate treatment of post-surgical pain can lead to decreased mobility, which increases the risks for medical complications, including deep vein thrombosis and partial lung collapse, potentially resulting in extended hospital stays. Over 23 million procedures per year result in moderate to severe post-operative pain in the major pharmaceutical markets (U.S., 5 main EU countries and Japan), resulting in $5.1 billion of acute pain treatment product sales in 2008. About ARX-01, the Sufentanil NanoTab PCA System ARX-01 is a pre-programmed, non-invasive, handheld system that allows post-operative patients to self-dose with sublingual Sufentanil NanoTabs to manage their post-operative pain. The ARX-01 System is designed to address the limitations of the current standard of care, IV PCA with morphine, by offering:
- A high therapeutic index opioid : Because ARX-01 uses the high therapeutic index opioid sufentanil, it offers post-operative pain patients the potential for effective patient-controlled analgesia with a low incidence of drug-related side effects.
- A non-invasive route of delivery : The sublingual route of delivery used in ARX-01 provides rapid onset of analgesia, therefore eliminating the risk of IV-related analgesic gaps and IV complications, such as catheter-related infections. In addition, because patients are not tethered to IV tubing and a pump for pain relief, ARX-01 allows for ease of patient mobility.
- A simple, pre-programmed PCA solution : ARX-01 is a pre-programmed PCA System designed to eliminate the risk of pump programming errors, which are a potential source of patient harm.