AcelRx Pharma (ACRX) to Present Data from Phase 3 SAP302 Study of ARX-04 as Pain Treatment

August 29, 2016 7:01 AM EDT

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AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced that the Company and its investigators will be presenting results from the Phase 3 SAP302 study of ARX-04 (sufentanil sublingual tablet, 30 mcg) in 76 patients who were treated for moderate-to-severe acute pain in the emergency department. An oral presentation reviewing these results, including the types of injuries that were sustained by patients in the study, will be made at the International Society for Burn Injuries (ISBI), which is taking place August 29 – September 1 in Miami, Florida.

As previously reported, adult patients treated with ARX-04 in this study experienced a mean pain intensity difference of 2.9 from a baseline of 8.1 on a validated 0 – 10 numeric rating scale at 60 minutes, meeting the study's primary objective. Injuries sustained by patients in SAP302 included fractures, sprains/strains, lacerations and burns, among others. Study participants tolerated ARX-04 well, with nausea (9%), somnolence (5%) and vomiting (4%) comprising the most commonly reported adverse events.

The study additionally concluded that ARX-04 had no overall impact on cognitive function.

Details on the presentation time are as follows:

Date:

Monday, August 29, 2016 at 1:30pm (local time)

Title:

Efficacy and Safety of Sublingual Sufentanil 30mcg for the Management of Acute Traumatic Pain in the Emergency Department

Authors:

Karen DiDonato, MSN, RN and Pamela Palmer, MD, PhD of AcelRx Pharmaceuticals, James Miner, MD of the Hennepin County Medical Center in Minneapolis, MN; Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; and Zubaid Rafique, MD of Baylor College of Medicine in Houston, TX

The International Society for Burn Injuries' first international congress took place in 1960. In 1965, delegates of the second congress moved to create a permanent organization with the goal of reducing the incidence of burns, as well as improving patient care, especially in developing countries. For more information on the 2016 Congress, please visit http://isbi2016.com.



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