AcelRx Pharma (ACRX) to Present Statistically Significant ARX-04 Phase 3 Data in Abdominoplasty Patients

September 22, 2016 4:05 PM EDT

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AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) announced that Dr. Shankar Lakshman, a board-certified plastic surgeon and AcelRx clinical investigator, will present a subgroup analysis from the SAP301 study at the annual meeting of the American Society of Plastic Surgeons (ASPS). SAP301 was a Phase 3 trial comparing placebo to ARX-04 (sufentanil sublingual tablet, 30 mcg) in 161 patients with moderate-to-severe acute pain following ambulatory abdominal surgery. Dr. Lakshman's presentation will focus on the reported activity of ARX-04 observed in the 80 patients who underwent abdominoplasty surgery. This cohort demonstrated statistical significance vs placebo (31.8 vs 17.6; p=0.001) for the primary efficacy endpoint of the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). Nausea, headache and dizziness were the most commonly reported adverse events in patients undergoing abdominoplasty and the rates of occurrence were similar between active and placebo treatment arms.

Details on the presentation time are as follows:


Saturday, September 24, 2016 at 1:15 PM to 3:15 PM (local time)


Phase 3 Results of Sublingual Sufentanil 30 mcg for the Management of Post-Operative Pain Following Abdominoplasty Surgery


Shankar Lakshman, MD of Pasadena Surgeons in Pasadena, CA; Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; Timothy Melson, MD of the Helen Keller Hospital in Sheffield, AL; and David Leiman, MD of the Victory Medical Center in Houston, TX

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