HAYWARD, Calif., May 6, 2021 /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 an investigator-initiated study to be conducted at The
CORE Institute Specialty Hospital in Phoenix, Arizona by the Musculoskeletal
Orthopedic Research and Education (MORE) Foundation evaluating the
perioperative use of DSUVIA (sufentanil sublingual tablet 30 mcg)
for patients undergoing hip or knee replacement as a same-day
surgical procedure.
MORE Foundation is a non-profit organization dedicated to
studying all musculoskeletal conditions and the leading causes of
disability and chronic pain. The principal investigator, Dr.
John Thompson, is an orthopedic
surgeon specializing in hip and knee replacement at The CORE
Institute, a nationally recognized orthopedic practice setting the
standard in musculoskeletal care through the delivery of
evidence-based medicine and standardized clinical protocols. The
CORE Institute Specialty Hospital recently received the 2021
America's 100 Best Hospitals for Joint Replacement Award for
superior clinical outcomes in knee and hip replacement.
The study is a prospective, randomized, patient-blinded,
continuous case series that will evaluate the efficacy and safety
of DSUVIA (sufentanil) for perioperative management of surgical
pain in 100 patients undergoing same-day hip or knee joint
replacement. The length of stay of patients receiving one dose of
DSUVIA (sufentanil) preoperatively and one dose postoperatively in
the postanesthesia care unit (PACU) is the primary endpoint and
will be compared to patients receiving standard of care
perioperative pain management. Secondary endpoints include average
total morphine milligram equivalents dosed per patient, ability to
complete physical therapy prior to discharge from the PACU, and
overall cost of the stay.
"Effective pain management is absolutely critical for patients
to be successfully discharged to home the same day as their hip or
knee replacement procedure," said Dr. Thompson. "I have begun to
order DSUVIA (sufentanil) and have been impressed with its ability
to control pain following these procedures while not contributing
to mental confusion or sedation, thereby allowing successful
discharge to home from the PACU. We are now interested in
conducting this prospective study to fully analyze the potential
benefits that can be obtained by using DSUVIA (sufentanil) as an
alternative to IV opioids in this patient population," continued
Dr. Thompson.
"One of the toughest challenges for anesthesiologists is
providing effective analgesia allowing same-day discharge following
joint replacement while avoiding sedation or confusion in the
patient," said Dr. Pamela Palmer,
co-founder and Chief Medical Officer of AcelRx. "Patients
undergoing these types of procedures are often of an advanced age
and the high peak plasma concentrations achieved with standard IV
bolus opioids can frequently lead to side effects that can delay
discharge. DSUVIA's (sufentanil's) blunted peak plasma
concentrations compared to IV bolus administration and lack of
cognitive impairment in patients as demonstrated in our Phase 3
study may allow these patients to be more awake and alert in the
PACU, thereby facilitating same-day discharge."
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. The
European Commission approved DZUVEO for marketing in Europe and the Company is currently in
discussions with potential European marketing partners.
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 MORE Foundation
The Musculoskeletal Orthopedic
Research and Education (MORE) Foundation is an Arizona non-profit corporation. MORE
Foundation pioneers innovative musculoskeletal research programs,
provides educational programs for the healthcare community, and
conducts charitable assistance programs that enhance access to
healthcare for vulnerable populations. MORE's community-focused
programs empower individuals to Keep Life in Motion®.
About The CORE Institute
The CORE Institute was
founded to fulfill a vision of excellence in patient care
encompassing the entire spectrum of orthopedic and neurosciences
care. The CORE Institute delivers integrated, comprehensive
musculoskeletal and neurological care. It is built upon a
foundation of pioneering research, academics, community service and
a passion for excellence in patient care. The organization
continues to be a leader in payor-reform initiatives, and it is at
the forefront of systems-based quality programs, which drive value
and improve the quality of patient care.
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), known 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
one product candidate, Zalviso® (sufentanil sublingual
tablet system, SST system, 15 mcg), an investigational product in
the U.S., is being developed as an innovatively designed
patient-controlled analgesia (PCA) system for reduction of
moderate-to-severe acute pain in medically supervised settings.
DZUVEO and Zalviso are both approved products in Europe.
For additional information about AcelRx, please visit
www.acelrx.com.
Forward-Looking Statements
This press
release contains forward-looking statements, including, but not
limited to, statements related to expected commencement of an
investigator-initiated study, the scope of the study, expected
analysis of clinical data, and the potential for DSUVIA to allow
joint replacement patients to be more awake and alert in the PACU.
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
"believes," "expects," "anticipates," "may," "will," "should,"
"seeks," "approximately," "intends," "plans," "estimates," or the
negative of these words or other comparable terminology. The
discussion of strategy, plans or intentions may also include
forward-looking statements. 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. In addition, such risks and uncertainties may
include, but are not limited to, those described in the Company'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). 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. The Company's SEC
reports are available at www.acelrx.com under the "Investors" tab.
Except to the extent required by law, the Company undertakes no
obligation to publicly release the result of any revisions to these
forward-looking statements to reflect events or circumstances after
the date hereof, or to reflect the occurrence of unanticipated
events.
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SOURCE AcelRx Pharmaceuticals, Inc.