AcelRx Pharmaceuticals announced top-line data showing that the open-label Phase 3 study of its investigational ARX-01 sublingual 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 IV PCA with morphine. 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.
Utilizing a randomized, open-label, parallel-group design, this study enrolled 359 adult patients and compared efficacy and safety of AcelRx’s investigational ARX-01 (15mcg/dose) to IV PCA with morphine (1mg/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 a minimum of 48 hours and up to 72 hours.
Results demonstrate that the Sufentanil NanoTab PCA System was non-inferior (P<0.001) to IV PCA morphine for the primary endpoint of PGA 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. As the 95% CI was +3.2% to +21.6% for the 48 hour PGA, 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 timepoints. 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).
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