Experts from the
Uniformed Services University of the Health Sciences
conclude that future battlefield medicine efforts should focus on
newer analgesics like DSUVIA® across military settings and
establish protocols for their implementation
HAYWARD,
Calif., Aug. 25, 2022 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for use in medically
supervised settings, today announced that an abstract entitled,
"Evolution Of Opioid Analgesia On The Battlefield For
Moderate-to-Severe Acute Pain" (abstract # A4123) was accepted for
e-Abstract presentation at the ANESTHESIOLOGY® 2022 annual meeting,
being held October 21-25, 2022 in
New Orleans, LA.
"The DSUVIA sufentanil sublingual tablet, or SST, is the only
transmucosal analgesic that is approved for the management of
moderate-to-severe acute pain in patients who are opioid-naive,
such as our soldiers in the military," stated Vince Angotti, Chief Executive Officer of
AcelRx. "Morphine has been the primary analgesic on the battlefield
since the 19th century, however, morphine has many
limitations, including a narrow therapeutic index. Over the past
few decades, an oral transmucosal fentanyl lozenge, indicated only
for cancer breakthrough pain, was introduced as an off-label
alternative to injectable morphine on the battlefield. As stated in
the abstract, there has been a high incidence of side effects with
the use of the lozenge, as well as the risk for addiction and
misuse."
Mr. Angotti continued, "DSUVIA is an alternative analgesic with
many potential advantages for use on the battlefield. The
Department of Defense, or DoD, recognized the therapeutic benefits
of potent opioids in acute trauma settings and aimed to improve
upon their application for the battlefield setting when providing
funding for the development of DSUVIA. We continue to work with
critical decision-makers at the DoD to facilitate the broad
roll-out of DSUVIA for our U.S. military."
In the abstract, the authors (Kim, et al.), all from
Uniformed Services University of the Health
Sciences, highlight the advantages of SST on the
battlefield, which include:
- High therapeutic index
- No active metabolites
- Analgesic onset within 15 minutes
- Maintains therapeutic levels for 3 hours
- No association with cognitive impairment
The authors conclude that, "future work should aim to improve
opioid products for the battlefield, discover non-opioid analgesic
options, and establish optimal drug administration protocol in
trauma settings".
E-Abstracts will be presented virtually and made available to
registrants throughout the entire meeting from Saturday,
October 22 (7:00 a.m. US Central Time) to Tuesday,
October 25, 2022 (3:00 p.m. U.S. Central Time). The
abstracts will remain available and open to meeting attendees for
three months after the meeting.
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, known as DZUVEO® in Europe, is indicated for use in adults in
certified medically supervised healthcare settings, such as
hospitals, surgical centers, and emergency departments, for the
management of acute pain severe enough to require an opioid
analgesic and for which alternative treatments are inadequate.
DSUVIA was designed to provide rapid analgesia via a non-invasive
route and to eliminate dosing errors associated with intravenous
(IV) administration. DSUVIA is a single-strength, solid dosage form
administered sublingually via a single-dose applicator (SDA) by
healthcare professionals. Sufentanil is an opioid analgesic
previously only marketed for 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. DZUVEO has been approved
by the European Medicines Agency and AcelRx's European
commercialization partner, Aguettant, will market the drug in
Europe.
This release is intended for investors only. For more
information, including important safety information and black box
warning for DSUVIA, please visit www.DSUVIA.com.
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 one
approved product in the U.S., DSUVIA® (sufentanil sublingual
tablet, 30 mcg), approved as DZUVEO® in Europe, indicated for the management of acute
pain severe enough to require an opioid analgesic for adult
patients in certified medically supervised healthcare settings, and
several product candidates. The Company's product candidates
include: two developmental pre-filled, ready-to-use syringes of
ephedrine and phenylephrine licensed for the U.S. from Aguettant;
Niyad™, a developmental device for use as a regional anticoagulant
for the extracorporeal circuit; LTX-608, for the potential
treatment of COVID-19, disseminated intravascular coagulation,
acute respiratory distress syndrome and acute pancreatitis; and
Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg),
an investigational product in the U.S. being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings.
This release is intended for investors only. For additional
information about AcelRx, please visit www.acelrx.com.
About Uniformed Services University of
the Health Sciences
The Uniformed Services University
(USU) of the Health Sciences, founded by an act of Congress in
1972, is the nation's federal health sciences university and the
academic heart of the Military Health System. USU students are
primarily active-duty uniformed officers in the Army, Navy, Air
Force and Public Health Service who receive specialized education
in tropical and infectious diseases, TBI and PTSD, disaster
response and humanitarian assistance, global health, and acute
trauma care. USU also has graduate programs in oral biology,
biomedical sciences and public health committed to excellence in
research. The University's research program covers a wide range of
areas important to both the military and public health. For more
information about USU and its programs,
visit www.usuhs.edu.
About the ANESTHESIOLOGY 2022 Annual Meeting
The ANESTHESIOLOGY Annual Meeting is the marquee annual event
for the American Society of Anesthesiologists®. Founded
in 1905, the American Society of Anesthesiologists is an
educational, research and scientific association
of physicians organized to raise the standards of the
medical practice of anesthesiology and to improve patient
care. As of 2021, the organization included more than 55,000
national and international members.
Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to the potential
adoption and benefits of DSUVIA for use in military settings. These
and any other forward-looking statements are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. These statements may be identified by the use of
forward-looking terminology such as "potential," "believe,"
"expect," "expected," "anticipate," "may," "will," "should,"
"seek," "approximately," "intends," "plans," "estimates,"
"benefits," or the negative of these words or other comparable
terminology. The discussion of financial trends, strategy, plans or
intentions may also include forward-looking statements, which are
predictions, projections and other statements about future events
that are based on current expectations and assumptions. These
forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
projected, anticipated or implied by such statements,
including: (i) risks relating to AcelRx's product development
activities and ongoing commercial business operations; (ii) risks
related to the ability of AcelRx to implement its development
plans, forecasts and other business expectations; (iii) risks
related to unexpected variations in market growth and demand for
AcelRx's commercial and developmental products and technologies;
and (iv) risks relating to our ability to obtain regulatory
approvals for our developmental product candidates. Although it is
not possible to predict or identify all such risks and
uncertainties, they may include, but are not limited to, those
described under the caption "Risk Factors" and elsewhere in
AcelRx's annual, quarterly and current reports (i.e., Form 10-K,
Form 10-Q and Form 8-K) as filed or furnished with the Securities
and Exchange Commission (SEC) and any subsequent public filings.
You are cautioned not to place undue reliance on any such
forward-looking statements, which speak only as of the date such
statements were first made. To the degree financial information is
included in this press release, it is in summary form only and must
be considered in the context of the full details provided in
AcelRx's most recent annual, quarterly or current report as filed
or furnished with the SEC. AcelRx's SEC reports are available at
www.acelrx.com under the "Investors" tab. Except to the extent
required by law, AcelRx undertakes no obligation to publicly
release the result of any revisions to these forward-looking
statements to reflect new information, events or circumstances
after the date hereof, or to reflect the occurrence of
unanticipated events.
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SOURCE AcelRx Pharmaceuticals, Inc.