AcelRx's DSUVIA(TM) Clinical Trial Results Selected as a "Top Abstract" for Oral Presentation at ASA's Annual Meeting - ANESTHESIOLOGY® 2017
REDWOOD CITY, Calif., Oct. 20, 2017 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx), a specialty pharmaceutical, today announced its clinical data presentation on the safety and efficacy of DSUVIA((TM))(sufentanil sublingual tablet), 30 mcg classified by age group across four clinical trials at the American Society of Anesthesiologists'(ASA) ANESTHESIOLOGY(® )2017 Annual Meeting. The information presented during the session was authored by Karen DiDonato, MSN, RN; Jacob Hutchins, MD; James Miner, MD; Harold Minkowitz, MD; and Pamela Palmer, MD, PhD.
"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 Pamela Palmer, MD, PhD, Co-Founder and Chief Medical Officer, AcelRx.
AcelRx will also host a breakfast satellite symposium that discusses the pharmacokinetics and dynamics of sublingual sufentanil tablets. This symposium will be led by Eugene Viscusi, MD; Albert Dahan, MD, PhD; and Dennis Fisher, MD.
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(R) 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(TM) (sufentanil sublingual tablet), 30 mcg
DSUVIA((TM)) (sufentanil sublingual tablet, SST, 30 microgram), known as ARX-04 outside the United States, is designed to treat moderate-to-severe acute pain and dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) in medically supervised settings. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia.( )The sufentanil pharmacokinetic profile when delivered sublingually potentially avoids the high peak plasma levels and short duration of action observed with IV administration. In the EU, the European Medicines Agency (EMA) has notified the company that the ARX-04 Marketing Authorization Application (MAA) is under scientific review.
Clinical and Rehabilitative Medicine Research Program (CRMRP)
DSUVIA((TM)) 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.
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. AcelRx's proprietary, non-invasive sublingual formulation technology delivers sufentanil with a consistent pharmacokinetic profile. The company is simultaneously developing ZALVISO(® )(sufentanil sublingual tablet system, SST system, 15 microgram) as an innovatively designed patient-controlled analgesia (PCA) system for treatment of moderate-to-severe pain in medically supervised settings. The company recently completed a Phase 3 clinical trial, IAP312, which included input from the FDA on the study protocol. This study was designed to evaluate the effectiveness of changes made to the functionality and usability of the ZALVISO device, to evaluate the incidence of inadvertent dosing, and to take into account comments from the FDA on the study protocol. AcelRx intends to resubmit the NDA for ZALVISO to the FDA by the end of the year. AcelRx has successfully received EU Marketing Approval for ZALVISO(®) in the EU. Grunenthal Group holds the rights for ZALVISO® in Europe, where a commercialization across multiple countries is underway. In June 2017, ZALVISO® was selected for a Red Dot Award in the category of Product Design - Life Sciences and Medicine.
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(TM) (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 AcelRx Pharmaceuticals, Inc.
