REDWOOD CITY, Calif.
Nov. 15, 2012
/PRNewswire/ -- 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 top-line data showing that the open-label Phase 3 study of its investigational sublingual (under the tongue) Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint of non-inferiority in patient global assessment (PGA) with method of pain control in comparison to intravenous (IV) PCA with morphine. Additional analyses also showed that in this study the NanoTab System was statistically significantly superior to IV morphine for the PGA measurement. In addition, using validated assessment tools, nurses managing patients in the study and the patients themselves reported that they had significantly greater Overall Satisfaction with the NanoTab System compared to IV PCA morphine and significantly greater Overall Ease of Care with the NanoTab System compared to IV PCA morphine.
"With these impressive top-line results from this head-to-head clinical trial, we have successfully completed an important step towards our New Drug Application (NDA) submission and, dependent on completing the remaining Phase 3 trials and obtaining FDA approval, eventual commercialization of the Sufentanil NanoTab PCA System," commented
, President and CEO, of AcelRx Pharmaceuticals, Inc. "Delivering patient-controlled analgesia in a non-invasive, pre-programmed system that provides powerful pain control while enhancing patient ease of care and satisfaction and nurse satisfaction compared to current invasive delivery systems will be a major advance for hospital care."
Utilizing a randomized, open-label, parallel-group design, this Phase 3 study enrolled 359 adult patients at 26 U.S. sites and compared efficacy and safety of AcelRx's investigational ARX-01 sublingual Sufentanil NanoTab PCA System (15 mcg/dose) to the commonly used IV PCA with morphine (1 mg/dose) for the treatment of acute post-operative pain immediately following major abdominal or orthopedic surgery. Patients were randomized 1:1 to treatment with the NanoTab System or IV PCA morphine and were treated for post-operative pain for a minimum of 48 hours and up to 72 hours.