BioCentury
ARTICLE | Clinical News

AcelRx gains on Phase III data for Sufentanil NanoTab System

November 16, 2012 1:52 AM UTC

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) gained $0.73 (23%) to $3.93 on Thursday after reporting that its Sufentanil NanoTab PCA System met the primary endpoint of non-inferiority to IV patient-controlled analgesia (PCA) with morphine in a Phase III trial to treat post-operative pain following major surgery. Specifically, Sufentanil NanoTab was non-inferior to PCA with morphine in the proportion of patients with Patient Global Assessment (PGA) pain control ratings of "good" or "excellent" over 48 hours after surgery (78.5% vs. 66.1%, p<0.001, 95% CI: 3.2%, 21.6%). AcelRx also performed a statistical analysis that showed that Sufentanil NanoTab was superior to morphine in the proportion of patients with PGA pain control ratings of "good" or "excellent" at 24, 48 and 72 hours (p=0.009). The open-label, U.S. Phase III trial enrolled 359 adults undergoing major abdominal or orthopedic surgery. ...