REDWOOD CITY, Calif.,
Nov. 17, 2016 /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 presentation
at the 15th Annual Pain Medicine Meeting of the American Society of
Regional Anesthesia and Pain Medicine (ASRA). The presentation is
part of the Emerging Technology Moderated Poster session and will
mark the first presentation of complete results from the Phase 3
SAP303 study of ARX-04 (sufentanil sublingual tablet, 30 mcg). The
study enrolled 140 patients aged ≥40 years who had undergone
short-stay in-patient or out-patient surgery. ASRA's Annual Pain
Medicine Meeting will take place November
17-19, 2016 in San Diego,
CA.
As was first reported in September, treatment with ARX-04 in
SAP303 was associated with a 49% reduction in mean pain intensity
from baseline (from 6.19 to 3.17 on a 0-10 numeric rating scale)
during the first 2 hours, and maintenance of that reduction for the
duration of the 12-hour study period. Pain relief was reported as
early as 15 minutes after the start of ARX-04 dosing, with the
majority of patients experiencing an overall decline in pain levels
from "high moderate" at baseline to "mild" by hour two. The
most frequently reported adverse events in the study population
were nausea (27%) and headache (6%). Baseline hepatic and/or renal
impairment was present in 29% of patients, but no differences in
adverse events were recorded between patients with normal and
impaired liver or renal function.
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Details on the
presentation are as follows:
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Title:
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A Phase 3 Open Label
Study of the Sufentanil Sublingual Tablet 30mcg for Treatment of
Acute Post-Operative Pain (Moderated Poster #3101)
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Authors:
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Harold Minkowitz, MD
of the Memorial Hermann Memorial City Medical Center in Houston,
TX; David Leiman, MD of the Hermann Drive Surgical Hospital in
Houston, TX; and Pamela P. Palmer, MD, PhD and Karen DiDonato, MSN,
RN of AcelRx Pharmaceuticals.
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Date/Time:
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Saturday, November
19, 2016; 10:45am-12:45pm
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Location:
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Session MP-10, Indigo
Room 202A, Hilton San Diego Bayfront Hotel
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The American Society of Regional Anesthesia and Pain Medicine
(ASRA) is one of the largest subspecialty medical societies in
anesthesiology with more than 4,000 members in 60 countries and 6
continents. For more information on the organization or its Annual
Pain Medicine Meeting, please visit www.asra.com.
Clinical and Rehabilitative Medicine Research Program
(CRMRP)
ARX-04 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 ARX-04
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.
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. The Company's
late-stage pipeline includes ARX-04 (sufentanil sublingual tablet,
30 mcg), designed for the treatment of moderate-to-severe acute
pain in medically supervised settings; and Zalviso® (sufentanil
sublingual tablet system), designed for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting. 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
as well as Norway, Iceland, and Liechtenstein 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, and Australia, while AcelRx retains all other
world-wide rights.
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,
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 U.S. Food and Drug
Administration, or FDA; AcelRx's pathway forward towards gaining
approval of Zalviso in the U.S.; anticipated resubmission of the
Zalviso NDA to the FDA; and the therapeutic and commercial
potential of AcelRx's product candidates, including potential
market opportunities for 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' ARX-04 development program; 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.
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SOURCE AcelRx Pharmaceuticals, Inc.