Sufentanil NanoTab PCA System: Phase III data
Top-line data from a double-blind, U.S. Phase III trial in 419 patients undergoing total unilateral knee or hip replacement surgery showed that Sufentanil NanoTab PCA System (15 µg/dose) taken every 20 minutes as needed for pain for at least 48 hours and up to 72 hours met the primary endpoint of improving SPID scores from baseline over the 48-hour period after the first dose vs. placebo (76.1 points vs. an 11.5 point reduction, p<0.001). Sufentanil NanoTab also met the secondary endpoints of improving SPID scores from baseline over 24 (33.8 points vs. an 8.8 point reduction, p<0.001) and 72 hours (166.2 points vs. a 2.6 point reduction, p<0.001) after the first dose vs. placebo. Additionally, Sufentanil NanoTab met the secondary endpoints of improving TOTPAR score at 48 hours and PGA with Method of Pain Control score at 48 hours vs. placebo (p<0.001 for both). The most common adverse events reported were nausea, vomiting, dizziness and itching. Patients in both groups were able to receive up to 2 mg/hour IV morphine as rescue medication. AcelRx said that pre-rescue pain scores were used to minimize the impact of rescue opioid on the efficacy data. ...