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AcelRx Pharmaceuticals Reports on ARX-04 Market and Landscape Presented at Analyst & Investor Event
Nathaniel Katz, MD; CEO of Analgesic Solutions, Adjunct Assistant Professor of Anesthesia at Tufts University School of Medicine
- Provided insights into the regulatory view of opioid approvals
David Leiman, MD; President of AIPM of Houston and Director of HD Research Corp
- Reviewed results of the ARX-04 clinical program: two pivotal, randomized, placebo-controlled studies, SAP202 and SAP301 (bunionectomy and outpatient abdominal surgery); and, two open-label Phase 3 studies, SAP302 and SAP303 (emergency department and ambulatory surgery)
Gina Ford; AcelRx Vice President, Commercial Strategy
- Explained the basis of AcelRx's expectations for the emergency department market opportunity, in terms of patient numbers and unmet need
- Provided guidance on AcelRx's anticipated pilot launch program
John Holcomb, MD; Retired COL, US Army, Division of Acute Care Surgery, Chief Center for Translational Injury Research, University of Texas Health Science Center, Houston, TX David Leiman, MD; President of AIPM of Houston and Director of HD Research Corp James Miner, MD; Chief of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN Michael Ritter, MD Emergency Medicine Physician, St. Joseph Health Mission Hospital, Mission Viejo, CA
- Offered informed views of the functions of an emergency department, and the decisions that physicians and nurses must make in order to prioritize patient care and outflow
- Discussed relative importance of speed and cost considerations when selecting pain medications and route of administration
"The event provided an opportunity for AcelRx and several key opinion leaders to share their outlook for ARX-04," commented
Clinical and Rehabilitative Medicine Research Program (CRMRP)
ARX-04 is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the
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.
AcelRx expects to submit a New Drug Application for ARX-04 with the
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
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Timothy E. Morris, Chief Financial Officer, 650.216.3511, firstname.lastname@example.org; Brian Korb, The Trout Group LLC, 646.378.2923, email@example.com