Presentation concludes that future battlefield
medicine efforts should focus on newer analgesics like DSUVIA®
across military settings and establish protocols for their
implementation in the trauma setting
HAYWARD,
Calif., Oct. 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 presented by
lead author, Sharon Kim, M.S., at
the ANESTHESIOLOGY® 2022 annual meeting, held October 21-25, 2022 in New Orleans, LA. The authors of the abstract,
from the nation's federal health sciences university, recommend the
adoption of a sufentanil sublingual tablet (SST), 30 mcg (or
DSUVIA®) by the Department of Defense (DoD) to improve pain
management in the battlefield setting.
In the abstract, the authors state, "In 2018, the DoD introduced
its newest synthetic opioid, sublingual sufentanil tablet (SST),
intended to be a more effective analgesic option" noting that SST
is the first oral mucosal opioid microtablet (3mm diameter)
designed to provide analgesia within as early as 15 minutes from
administration, maintain therapeutically effective analgesic levels
for up to 3 hours, and reduce the risk of dosing errors through its
innovative applicator design. The authors then highlight that "the
sublingual tablet has a bioadhesive surface to adhere to the
oral mucosa, minimizing salivary response and swallowing" and state
that the "sublingual administration enables a longer drug plasma
half-life allowing for more consistent plasma concentrations over
time and eliminating the need for repeated dosing. Since sublingual
sufentanil has a high therapeutic index with no active metabolites,
drug administration incurs minimal side-effects (e.g., nausea,
dizziness, headache) and is not associated with cognitive
impairment." The therapeutic index of a drug is the margin of
safety that exists between the dose of a drug that
produces the desired effect and the dose that produces unwanted and
possibly dangerous side effects.
The authors continued by noting that, in contrast to morphine
and fentanyl, sublingual sufentanil has minimal euphoric effects
that commonly drive opioid addiction. In particular, the authors
identified the combination of the tablet formulation and sublingual
delivery of the SST provides a low peak drug plasma concentration,
thus avoiding the initial high peak opioid concentrations
responsible for adverse events. The authors acknowledged that
"to date, no transmucosal opioid products are approved for the
treatment of moderate-to-severe acute pain in patients who are
opioid-naive, demonstrating the medical benefits of SSTs."
The authors concluded, "Overall, the DoD recognizes the
therapeutic benefits of potent opioids in acute trauma settings and
has aimed to improve battlefield opioid usage, which evolved from
IV morphine administration to [fentanyl] lollipops to finally SSTs.
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."
"DSUVIA offers an alternative for pain relief with many
potential advantages for use on the battlefield including ease of
dosing, rapid onset and a high therapeutic index," stated
Vince Angotti, Chief Executive
Officer of AcelRx. As the military acknowledges, DSUVIA is the only
transmucosal opioid that is approved for patients who are
opioid-naive, such as our soldiers in the military. The Department
of Defense, or DoD, has repeatedly recognized the need for a
product like DSUVIA, a novel sublingual tablet which they believe
should provide a safer alternative to our soldiers for pain relief
compared to existing options. We continue to work with the critical
decision-makers at the Department of Defense to make this important
drug available to our men and women serving in our U.S.
military."
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)
through 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.
History of Pain Management in the Military
Setting
Morphine has been the primary analgesic on the
battlefield since the 19th century and was originally developed as
a less addictive alternative to opium. However, the drug has a
narrow therapeutic index (TI), and morphine abuse and overdose
continued into World War II and the 20th century. Even after the
inception of morphine over a century ago, the U.S. military has
used intramuscular (IM) morphine for battlefield analgesia,
although disadvantages include inconsistent absorption, delayed
onset, and compromised pain relief. In 1996, the Department of
Defense (DoD) developed the Tactical Combat Casualty Care (TCCC)
guidelines for trauma life support and pain management in
prehospital combat settings. The 1996 TCCC guidelines stated that
IV morphine is preferable to IM morphine due to the more rapid
onset of action, providing faster pain relief and decreasing the
risk for overdose. The DoD then shifted focus to introducing
opioids that can be administered through the oral or nasal mucosa
when IV access is unfeasible. In 2004, the DoD added oral
transmucosal fentanyl citrate (OTFC) to the TCCC guidelines. OTFC
was primarily used to treat intense cancer pain but was recommended
for off-label use on the battlefield. OTFC is packaged as a lozenge
on a handle (like a lollipop) and quickly absorbed through the oral
mucosa. Some fentanyl that is swallowed is absorbed through the
gastrointestinal tract. Disadvantages of OTFC include a high
incidence of side-effects (nausea, vomiting, respiratory
depression, sedation) and risk for opioid addiction and
misuse.1
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.
References
1 Kim, Sharon, et al.
"Evolution Of Opioid Analgesia On The Battlefield For
Moderate-to-Severe Acute Pain" Abstract A4123 – ANESTHESIOLOGY
2022, New Orleans, LA.
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," "offer", "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 AcelRx's
ability to obtain regulatory approvals for its 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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