REDWOOD CITY, Calif.,
Feb. 13, 2017 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for the treatment of moderate-to-severe acute
pain, announced an upcoming podium presentation of comprehensive
results from the DSUVIA™ SAP302 study of patients who presented to
emergency departments with moderate-to-severe acute pain resulting
from trauma or injury, including burns. The presentation will take
place at the annual John A. Boswick,
M.D. (JAB) Burn and Wound Care Symposium February 12-16, 2017 in Maui, Hawaii.
Included in this presentation are case studies of a 26-year-old
female with a second-degree burn of the anterior right thigh and a
49-year-old male with second and third-degree burns over 13% of his
body. Both reported a baseline pain intensity of 8 on a validated
10-point scale and were administered DSUVIA as part of the SAP302
study in emergency room patients with moderate to severe acute
pain. After a single DSUVIA dose, each patient reported a
2-point decrease in pain intensity within 15 minutes. No adverse
events were observed in either patient. In the SAP302 trial, the
majority of patients experienced no adverse events. Among those who
did experience side effects, the most commonly reported were nausea
(9%), somnolence (5%) and vomiting (4%).
According to the most recent National Hospital Ambulatory Care
Survey, each year approximately 500,000 persons present to U.S.
emergency departments with burns, and 40,000 are hospitalized.
Dr. Pamela Palmer, co-founder and
chief medical officer at AcelRx, explained, "Tissue damage from a
severe burn is one of the most painful and disfiguring forms of
trauma. While opioids are the standard-of-care to address the
moderate-to-severe acute pain from burns, damaged tissue can make
intravenous (IV) access difficult. With a product like DSUVIA,
emergency physicians would have the option to administer a
non-invasive opioid that potentially provides patients analgesia
within 15-30 minutes."
Details on the presentations are as follows:
Title:
|
Safety and Efficacy
of the Sufentanil Sublingual Tablet 30mcg (SST 30mcg) for Treatment
of Moderate-to-Severe Acute Pain in the Emergency
Department
|
Presenter:
|
Karen DiDonato, MSN,
RN of AcelRx Pharmaceuticals
|
Time/Place:
|
Wednesday, February
15, 2017 at 8:30am
|
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 DSUVIA (Formerly ARX-04)
DSUVIA 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.
DSUVIA is an investigational product candidate and is not
approved in any geography.
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. An NDA for
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, was submitted to the FDA for
review in December 2016.
The Company's follow on product, ZALVISO® (sufentanil sublingual
tablet system), designed for the management of moderate-to-severe
acute pain in adult patients in the hospital setting, is currently
enrolling patients in a Phase 3 clinical trial, IAP312. ZALVISO
delivers 15 mcg sufentanil sublingually through a non-invasive
delivery route via a pre-programmed, patient-controlled analgesia
device. ZALVISO is approved in the EU and is investigational and in
late-stage development in the U.S. Grunenthal Group holds the
rights for ZALVISO in Europe,
where a commercial launch has begun.
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,
DSUVIATM (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; the potential approval of
the DSUVIA NDA by the FDA; the DSUVIA and ARX-04 clinical trial
results; AcelRx's pathway forward towards gaining approval of
ZALVISO in the U.S., including successful completion of the IAP312
clinical study for ZALVISO; and the therapeutic and commercial
potential of AcelRx's product candidates, including potential
market opportunities for DSUVIA, ARX-04 and ZALVISO. 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 FDA review of the DSUVIA NDA and the possibility that
the FDA may dispute or interpret differently clinical results
obtained from the DSUVIA Phase 3 studies; the ZALVISO development
program, including successful completion of IAP312 and 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; 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
November 2, 2016. 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-presentation-at-jab-burn-symposium-highlights-potential-of-dsuvia-for-use-in-burn-victims-with-moderate-to-severe-acute-pain-300405869.html
SOURCE AcelRx Pharmaceuticals, Inc.