AcelRx Pharmaceuticals announced the start of the second Phase 3 study for Sufentanil NanoTab PCA System, ARX-01.
This second study will enroll approximately 400 patients in a multicenter, randomized, open-label, parallel-group design, comparing the efficacy and safety of the Sufentanil NanoTab PCA System to the standard of care, IV PCA with morphine, in the treatment of acute post-operative pain immediately after major abdominal or orthopedic surgery. The primary objective of the study is to demonstrate non-inferiority of ARX-01 to IV PCA with morphine as determined by patient global satisfaction with the method of pain relief. Patients will be randomized 1:1 to treatment with ARX-01 or IV PCA with morphine, for post-operative pain for >48 hours after randomization. Data is expected in the second half of 2012.
A third Phase 3 study for ARX-01, expected in the third quarter of 2012, will be a randomized, double-blind, placebo-controlled efficacy and safety study comparing ARX-01 to placebo in treating post-operative pain following major joint replacement surgery.
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.
For more information call (650) 216-3500 or visit www.acelrx.com.