News Release

AcelRx Pharmaceuticals Unveiling Results of ARX-04 SAP303 Study in Post-Operative Setting at the Annual ASRA Pain Medicine Meeting
As was first reported in September, treatment with ARX-04 in SAP303 was associated with a 49% reduction in mean pain intensity from baseline (from 6.19 to 3.17 on a 0-10 numeric rating scale) during the first 2 hours, and maintenance of that reduction for the duration of the 12-hour study period. Pain relief was reported as early as 15 minutes after the start of ARX-04 dosing, with the majority of patients experiencing an overall decline in pain levels from "high moderate" at baseline to "mild" by hour two. The most frequently reported adverse events in the study population were nausea (27%) and headache (6%). Baseline hepatic and/or renal impairment was present in 29% of patients, but no differences in adverse events were recorded between patients with normal and impaired liver or renal function.
Details on the presentation are as follows: |
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Title: |
A Phase 3 Open Label Study of the Sufentanil Sublingual Tablet 30mcg for Treatment of Acute Post-Operative Pain (Moderated Poster #3101) |
Authors: |
Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; David Leiman, MD of the Hermann Drive Surgical Hospital in Houston, TX; and Pamela P. Palmer, MD, PhD and Karen DiDonato, MSN, RN of AcelRx Pharmaceuticals. |
Date/Time: |
Saturday, November 19, 2016; 10:45am-12:45pm |
Location: |
Session MP-10, Indigo Room 202A, Hilton San Diego Bayfront Hotel |
Clinical and Rehabilitative Medicine Research Program (CRMRP)
ARX-04 is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the
In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).
About ARX-04
ARX-04 is a non-invasive investigational product candidate consisting of 30 mcg sufentanil tablets delivered sublingually by a healthcare professional using a disposable, pre-filled, single-dose applicator (SDA). Sufentanil is a synthetic opioid analgesic with a high therapeutic index and no known active metabolites.
About
For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx's product candidates, ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso® (sufentanil sublingual tablet system), including the ARX-04 clinical trial results; anticipated submission of the New Drug Application, or NDA, for ARX-04 to the
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SOURCE
Timothy E. Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com; Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com