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Phase III Trial Compares Sublingual Sufentanil and IV Morphine for Postoperative Pain

Nurses and patients report greater satisfaction and ease of care with sufentanil (Nov. 15)

An open-label phase III study of sublingual sufentanil has met its primary endpoint of non-inferiority in patients’ global assessment (PGA) of the method of pain control compared with intravenous (IV) patient-controlled analgesia (PCA) with morphine.

In addition, both nurses and patients reported that they had significantly greater overall satisfaction and significantly greater overall ease of care with the investigational ARX-01 sublingual Sufentanil NanoTab PCA System (AcelRx Pharmaceuticals) compared with IV PCA with morphine.

The phase III, open-label, randomized, parallel-group trial compared the efficacy and safety of the sublingual sufentanil system (15 mcg/dose) with that of IV PCA with morphine (1 mg/dose) for the treatment of acute postoperative pain immediately following major abdominal or orthopedic surgery in 359 adult patients. The patients were randomly assigned to PCA with sublingual sufentanil or IV morphine and were treated for postoperative pain for 48 to 72 hours.

PCA with sublingual sufentanil was found to be non-inferior to PCA with IV 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; P < 0.001). A statistical analysis for superiority demonstrated that sublingual sufentanil was statistically superior to IV morphine for the PGA endpoint (P = 0.009). In addition, the percentage of patients rating sublingual sufentanil as "excellent" was higher than the percentage of those giving IV morphine the same rating (42.9% vs. 30.6%, respectively; P = 0.016).

Similar proportions of patients treated with sublingual sufentanil and IV morphine discontinued the study prematurely because of lack of efficacy (7.3% vs. 8.3%, respectively) or the occurrence of an adverse event (7.9% vs. 11.1%, respectively).

Nurses setting up the two treatments for use and managing patients in the study reported that they had greater overall satisfaction with sublingual sufentanil versus IV morphine (3.93 vs. 3.32 out of 5.00, respectively; P < 0.001) and greater overall ease of care (4.26 vs. 3.82 out of 5.00; P = 0.018). Similarly, patients in the study reported that they had greater overall satisfaction (4.15 vs. 3.83 out of 5.00; P = 0.003) and greater overall ease of care (4.45 vs. 4.07 out of 5.00; P < 0.001) with sublingual sufentanil versus IV morphine.

ARX-01 is an investigational pre-programmed, noninvasive, handheld system that allows postoperative patients to self-dose with sublingual Sufentanil NanoTabs to manage their postoperative pain.

Source: AcelRx Pharmaceuticals; November 15, 2012.

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