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AcelRx Top-line Data Show Primary Endpoint Achieved in Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Post-Operative Pain in Major Open Abdominal Surgery Patients
Date:3/4/2013

o-controlled design, this pivotal Phase 3 study enrolled 178 adult patients at 13 U.S. sites for the treatment of acute post-operative pain immediately following major abdominal surgery.  Patients were treated for post-operative pain for a minimum of 48 hours, and up to 72 hours.  Patients were randomized 2:1, with 119 patients randomized to sufentanil and 59 to placebo treatment.  Both treatments were delivered by the patient, as needed, using the NanoTab System with a 20-minute lock-out period.  Patients in both groups could receive up to 2 mg morphine intravenously per hour as a rescue medication, the primary purpose of this rescue medication being to provide placebo-treated patients access to pain medication to enable them to stay in the study as long as possible.  Pre-rescue pain scores were imputed to minimize the impact of this rescue opioid on efficacy evaluations.

Eighty, or 70.2% of the sufentanil NanoTab-treated patients completed the 48-hour study period, compared to 30 (51.7%) placebo-treated patients.  Reasons for drop-out in the sufentanil- and placebo-treated groups were adverse events (5.3% and 6.9% respectively), lack of efficacy (16.7% and 31.0% respectively) and other (7.9% and 10.3% respectively).  The primary endpoint measure, SPID-48, was 105.6 for sufentanil-treated patients and 55.6 for placebo-treated patients (p=0.001). 

Treatment-emergent adverse events occurred in 64.0% of sufentanil-treated patients and 67.2% of placebo-treated patients.  Adverse events with an occurrence greater than 5% in either the sufentanil group or the placebo group were nausea (30.7% and 41.4% respectively), fever (14.9% and 8.6% respectively), vomiting (8.8% and 6.9% respectively), itching (8.8% and 0.0% respectively), oxygen saturation decrease (6.1% and 1.7% respectively), and hypertension (2.6% and 5.2% respectively).  Itching, a frequently observed side effect of opioids, was the only adverse e
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SOURCE AcelRx Pharmaceuticals, Inc.
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