In response to opinions expressed following the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee meeting on October 12, AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX) stands by the safety, efficacy and medical need for its investigational therapy, DSUVIA™.
REDWOOD CITY, Calif., Oct. 19, 2018 /PRNewswire/ -- In response to opinions expressed following the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee meeting on October 12, AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX) stands by the safety, efficacy and medical need for its investigational therapy, DSUVIA™. Developed in collaboration with the Department of Defense, DSUVIA potentially represents an important non-invasive, rapidly acting alternative to IV opioids, the current standard of care for acute pain management in medically supervised settings.
We appreciate the thoughtful and thorough discussion among the 13 committee members, as well as the forum for public commentary. The Committee voted 10-3 in favor of recommending the approval of DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings for adult patients. AcelRx is committed to continued collaboration with the FDA on the new drug application for DSUVIA.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA (sufentanil sublingual tablet, 30 microgram), known as DZUVEO™ outside the United States, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings, in adult patients and was designed to eliminate dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) administered by health care professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018.
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 use in medically supervised settings. 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 DZUVEO in Europe, 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 mcg) being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.
For additional information about AcelRx’s clinical programs, please visit www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.
Company Codes: NASDAQ-NMS:ACRX
