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AcelRx Pharmaceuticals to Present ARX-04 Analysis for Treatment of Moderate-to-Severe Acute Pain in Obese Patients at The Obesity Society Annual Meeting
This poster presents data that shows that obese patients treated with ARX-04 (sufentanil sublingual tablet, 30 mcg) in the Phase 3 SAP301 study following ambulatory abdominal surgery experienced greater pain relief over the 12-hour study period (SPID-12) compared to those treated with a placebo. The experience of obese patients in the study was similar to that of patients with lower BMIs. Nausea (23%) and headache (10%) were the only adverse events reported by more than one patient in the obese cohort treated with ARX-04. Overall, while sample sizes were limited, the conclusion of this analysis was that safety and efficacy results were consistent across the entire study population, regardless of BMI.
Details on the presentations are as follows: |
|
Date: |
Friday, November 4th, 12:00 – 1:30 p.m. (local time) |
Title: |
The Sufentanil Sublingual 30mcg Tablet and Effect of BMI on Post-Operative Pain Management Following Outpatient Abdominal Surgery |
Authors: |
Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; Shankar Lakshman, MD of Lotus Clinical Research in Pasadena, CA; Timothy Melson, MD of the Helen Keller Hospital in Sheffield, AL; David Leiman, MD of the Victory Medical Center in Houston, TX; and Karen DiDonato, MSN, RN and Pamela Palmer, MD, PhD of AcelRx Pharmaceuticals |
Dr.
ObesityWeek is a unique, international event focused on the basic science, clinical application, surgical intervention and prevention of obesity. By combining both
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
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-to-present-arx-04-analysis-for-treatment-of-moderate-to-severe-acute-pain-in-obese-patients-at-the-obesity-society-annual-meeting-300353649.html
SOURCE
Timothy E. Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com; or Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com