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AcelRx Pharmaceuticals Inc Presents Top-Line Data From Phase 3 Study Of Sufentanil NanoTab PCA System vs. IV PCA Morphine


Friday, 14 Dec 2012 07:30am EST 

AcelRx Pharmaceuticals Inc announced top-line data from previously announced open-label, active-comparator study of lead product candidate, the Sufentanil NanoTab PCA System. Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil NanoTab PCA System was non-inferior (p <0.001) to intravenous (IV) patient-controlled analgesia (PCA) with morphine for primary endpoint of Patient Global Assessment (PGA) of method of pain control over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of good or excellent (78.5% vs. 66.1% respectively). The assessment of non-inferiority is based on a lower limit of -15% for the 95% confidence interval (CI) around the difference between these percentages. Because the 95% CI was +3.2% to +21.6% for the 48-hour PGA, a statistical analysis for superiority could be performed, which demonstrated that for this study, the NanoTab System was statistically superior to IV PCA morphine for the PGA endpoint (p=0.009). This statistically superior PGA was also seen at the 24 hour and 72 hour time points. Additionally, the percentage of patients rating the NanoTab System as Excellent was higher than those rating IV PCA morphine as excellent (42.9% vs. 30.6%, p=0.016). Similar percentages of NanoTab System-treated and IV PCA morphine-treated patients dropped out of the study prematurely due to lack of efficacy (7.3% vs. 8.3% respectively) or due to an adverse event (7.9% vs. 11.1% respectively). 

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19 Aug 2014