REDWOOD CITY, Calif., Oct. 31, 2016 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced an upcoming poster presentation at The Obesity Society Annual Meeting, which is taking place October 31 - November 4, 2016 in New Orleans, LA.
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:
Friday, November 4th, 12:00 – 1:30 p.m. (local time)
The Sufentanil Sublingual 30mcg Tablet and Effect of BMI on Post-Operative Pain Management Following Outpatient Abdominal Surgery
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. Pamela Palmer, chief medical officer and co-founder of AcelRx added, "Obese patients require careful weight-based dosing regimens when using many opioid pain medications, such as morphine. The evidence from this study suggests that ARX-04 has the potential for fixed-dose pain management for these patients."
ObesityWeek is a unique, international event focused on the basic science, clinical application, surgical intervention and prevention of obesity. By combining both American Society for Metabolic & Bariatric Surgery (ASMBS) and The Obesity Society (TOS) annual meetings, ObesityWeek brings together world-renowned experts in obesity to share innovation and breakthroughs in science unmatched around the globe. Attendees will enjoy the diverse educational opportunities, networking events, and scientific synergies created through the collaboration of these leading obesity organizations. More information may be found at http://obesityweek.com.
Clinical and Rehabilitative Medicine Research Program (CRMRP)
ARX-04 is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries.
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).
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 AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain. The Company's late-stage pipeline includes ARX-04 (sufentanil sublingual tablet, 30 mcg), designed for the treatment of moderate-to-severe acute pain in medically supervised settings; and Zalviso® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. Zalviso is approved in the EU as well as Norway, Iceland, and Liechtenstein and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx retains all other world-wide rights.
For additional information about AcelRx's clinical programs, please visit www.acelrx.com.
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 U.S. Food and Drug Administration, or FDA; AcelRx's pathway forward towards gaining approval of Zalviso in the U.S.; anticipated resubmission of the Zalviso NDA to the FDA; and the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities for ARX-04 and Zalviso. These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals' actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals' ARX-04 development program, including anticipated submission of the ARX-04 NDA and resubmission of the Zalviso NDA; the uncertain clinical development process; the success, cost and timing of all development activities and clinical trials; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on July 29, 2016. AcelRx undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.
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Last updated on: 31/10/2016
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