REDWOOD CITY, Calif., Nov. 9, 2017 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, reported the publication of a manuscript analyzing sufentanil sublingual tablet 30 mcg for moderate-to-severe acute pain in the emergency department (ED) in the peer-reviewed journal, The American Journal of Emergency Medicine. This manuscript reports on the results of an open-label, multicenter feasibility study which included opiate-naïve patients who presented to the ED with moderate-to-severe pain due to trauma or injury. Conclusions of this study indicated that sufentanil sublingual tablet 30 mcg demonstrated clinically meaningful management of moderate-to-severe acute pain in an ED setting.
"Despite pain being the most common reason that patients present to the ED, there are several limitations with the current treatment options available," commented Dr. James Miner, Chief of Emergency Medicine at the Hennepin County Medical Center. "The use of sufentanil sublingual tablets is particularly promising as it could lead to more efficient acute pain treatment, thereby potentially reducing the length of stay, which benefits both the patient and the ED."
Details on the publications:
Miner J, Rafique Z, Minkowitz H, DiDonato K, Palmer P. Sufentanil sublingual tablet 30 mcg for moderate-to-severe acute pain in the emergency department. The American Journal of Emergency Medicine. Nov 2017 [Epub ahead of print].
About the Journal:
The American Journal of Emergency Medicine (AJEM) is a key source for information on emergency medical care. The journal covers all activities concerned with emergency medicine and contains information to help increase the ability to understand, recognize and treat emergency conditions. Issues contain clinical articles, case reports, review articles, editorials, international notes and book reviews.
About DSUVIA™ (Sufentanil Sublingual Tablet, 30 mcg)
DSUVIA™ (sufentanil sublingual tablet, SST, 30 microgram), known as ARX-04 outside the United States, is designed to reduce 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™ 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 consistent pharmacokinetic profiles. The company has two product candidates including DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, and ZALVISO® (sufentanil sublingual tablet system, SST system, 15 microgram) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings.
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, 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; 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, 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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