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AcelRx's DSUVIA™ Clinical Trial Results Selected as a "Top Abstract" for Oral Presentation at ASA's Annual Meeting - ANESTHESIOLOGY® 2017
"We are honored to be one of the top eight abstracts featured as an oral presentation at the Frontiers in Opioid Pharmacotherapy symposium at ANESTHESIOLOGY® 2017. Our inclusion in this important symposium acknowledges the potential clinical relevance of DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings," said
AcelRx will also host a breakfast satellite symposium that discusses the pharmacokinetics and dynamics of sublingual sufentanil tablets. This symposium will be led by
The ANESTHESIOLOGY® 2017 Annual Meeting is hosted by the American Society of Anesthesiologists (ASA) and is taking place on October 21-25 in Boston, Massachusetts. ANESTHESIOLOGY 2017 is expected to welcome nearly 15,000 attendees. For more information on ASA, please visit www.asahq.org.
Details of the presentations are as follows:
Title: |
Safety and Efficacy of Sufentanil Sublingual Tablet 30 mcg by Age Group for the Treatment of Acute Pain in Medically Supervised Settings |
Authors: |
Karen DiDonato, MSN, RN of AcelRx Pharmaceuticals; Jacob Hutchins, MD of the University of Minnesota in Minneapolis, MN; 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; Pamela Palmer, MD, PhD of AcelRx Pharmaceuticals |
Time/Place: |
9:00 am – 12:00 pm on October 22, 2017 at the Westin Boston Waterfront Grand Meeting Room 206 A/B |
Title: |
ASA® Non-Accredited Satellite Symposium: Pharmacokinetics and Dynamics of Sublingual Sufentanil |
Authors: |
Eugene Viscusi, MD, Professor, Jefferson University Hospitals in Philadelphia, PA; Albert Dahan, MD, PhD, Professor, Leiden University Medical Center in Leiden, Netherlands; and Dennis Fisher, MD, Professor Emeritus, University of California, San Francisco. |
Time/Place: |
6:30 am – 8:00 am on October 23, 2017 at the Westin Boston Waterfront Grand Ballroom B - E |
About DSUVIA™ (sufentanil sublingual tablet), 30 mcg
DSUVIA™ (sufentanil sublingual tablet, SST, 30 microgram), known as ARX-04 outside the
Clinical and Rehabilitative Medicine Research Program (CRMRP)
DSUVIA™ 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).
About AcelRx Pharmaceuticals, Inc.
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, DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, and ZALVISO® (sufentanil sublingual tablet system), including U.S. Food and Drug Administration, or FDA, review of the New Drug Application, or NDA, for DSUVIA; and evaluation of the CRL and AcelRx's plans for resubmission of the NDA for DSUVIA with the FDA. 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' DSUVIA and ARX-04 development programs, including the EMA review of the ARX-04 MAA, and the possibility that EMA may dispute or interpret differently clinical results obtained from the ARX-04 Phase 2 and 3 studies; the possibility that the FDA may dispute or interpret differently the results of the ZALVISO development program, including the results from the IAP312 clinical trial; the resubmission of the ZALVISO NDA to the FDA; any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical development process, including adverse events; 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 August 2, 2017. 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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SOURCE
Investors: Brian Korb, The Trout Group LLC, 646-378-2923, bkorb@troutgroup.com or Raffi Asadorian, Chief Financial Officer, AcelRx Pharmaceuticals, rasadorian@acelrx.com or Media: Stephanie Eisenstat, Medical Dynamics, 646-599-8627, seisenstat@rxmedyn.com