A phase 3 non-inferiority trial comparing the Sufentanil NanoTab® PCA System to IV morphine PCA for the treatment of acute post-operative pain

IV PCA morphine is standard of care in many hospitals for managing post-operative pain, but is often associated with limitations, including programming errors, reduced patient mobility and infiltrated IVs. Whereas morphine can produce side effects from accumulation of active metabolites, sufentanil has a high therapeutic index and minimal pharmacokinetic differences based on age, liver or kidney function. Its rapid IV redistribution and short duration of action make it nonviable for IV PCA use. The Sufentanil NanoTab PCA System (ARX-01) is a novel preprogrammed, noninvasive PCA product candidate in Phase 3 development that dispenses sufentanil 15 mcg tablets sublingually with a 20-minute lockout. This Phase 3 randomized, non-inferiority trial was conducted at 26 US sites. Adult inpatients after major open abdominal surgery or orthopedic surgery (knee/hip replacement) were randomized 1:1 to ARX-01 or morphine IV PCA (1 mg q 6-minute lockout) for up to 72h. This study was designed to assess the ability of the two PCA systems to produce comparable patient satisfaction with the method of pain control. The 48-hour Patient Global Assessment was defined as the primary endpoint. Pain intensity and pain relief scores were obtained as secondary endpoints. To demonstrate therapeutic non-inferiority, 359 patients were randomized which provided 90% power. A 95% confidence interval of the difference in success rate between two treatment groups was constructed to determine non-inferiority of the two treatments. At the time of this abstract patient dosing was completed, and data from the study was being collected and analyzed. It is anticipated that the complete dataset will be available and presented at the meeting. Based upon the previously presented Phase 2 and other data, the Sufentanil NanoTab PCA System appears to be a promising non-invasive alternative to morphine IV PCA that avoids the risk of pump programming errors. Sponsored by AcelRx Pharmaceuticals.