BioCentury
ARTICLE | Clinical News

AcelRx meets primary endpoint in Phase III pain trial

March 6, 2013 2:28 AM UTC

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) said Sufentanil NanoTab PCA System met the primary endpoint in a Phase III trial to treat post-operative pain in patients undergoing major abdominal surgery. Specifically, Sufentanil NanoTab significantly improved summed pain intensity difference scores from baseline over the 48-hour period after the first dose vs. placebo (105.6 vs. 55.6 points, p=0.001). The double-blind, U.S. trial enrolled 178 adults who were also able to receive IV morphine as rescue medication.

Last year, AcelRx reported top-line data from a Phase III trial in adults undergoing major abdominal or orthopedic surgery showing that Sufentanil NanoTab met the primary endpoint of non-inferiority to IV patient-controlled analgesia (PCA) with morphine (see BioCentury Extra, Nov. 15, 2012). ...