REDWOOD CITY, Calif.,
Aug. 19, 2020 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for use in medically supervised settings,
today announced the publication of a study entitled "Reduced Opioid
Use and Reduced Time in the Postanesthesia Care Unit Following
Preoperative Administration of Sublingual Sufentanil in an
Ambulatory Surgery Setting" by Christian
Tvetenstrand, MD and Michael
Wolff, MD, in the Journal of Clinical Anesthesia and Pain
Management.
"The observations in this study strongly support utilizing
DSUVIA over intravenous bolus opioids, consistent with opioid
stewardship programs and enhanced recovery after surgery protocols,
which focus on minimizing opioid dosing in multimodal analgesic
protocols," said Dr. Christian
Tvetenstrand, Chairman of Surgery and Director of
Trauma, United Health Services Wilson Medical Center,
New York. "I strongly believe this
data on preoperative DSUVIA administration will result in a
paradigm shift in pain management protocols across all ambulatory
surgeries, as we have already seen significant cost savings due to
less medical intervention and improved patient recovery."
The study compared a prospective group of patients with
preoperative dosing of a single sublingual DSUVIA tablet to a
historical control group receiving standard intravenous (IV) opioid
administration for same-day general surgery procedures. A total of
127 patients were evaluated in the study, with the following key
findings:
- Discharge from the PACU occurred 34% faster than controls (36.3
min vs. 54.9 min; p < 0.001).
- Significantly fewer DSUVIA treated patients required
intraoperative IV opioid following preoperative dosing with DSUVIA
compared with the control group (61.7% vs. 97.5%, respectively; p
< 0.001).
- DSUVIA patients received a total preoperative and
intraoperative mean opioid dose of 10.9 milligram morphine
equivalents (MME), while the mean dose for controls was 20.0 mg MME
(p < 0.001).
- Fewer DSUVIA-treated patients required any postoperative opioid
(10.5% vs. 63.0%; p < 0.001) with overall opioid utilization
being reduced by over 50% with DSUVIA use throughout the
perioperative setting (11.8 MME vs. 24.6 MME; p <
0.001).
- Significantly fewer patients in the DSUVIA group received
adrenergic agonists and IV acetaminophen.
The study concluded that the preoperative administration of
DSUVIA results in significant reductions in opioid use during
outpatient surgery and facilitates shorter PACU stays. Study
limitations include that it was an open-label study, the
retrospective nature of the control group, and the focus on only
general surgery patients.
"The results of this study build on an ever-increasing clinical
dataset demonstrating the benefits of sublingual sufentanil. The
standard of care for perioperative opioid administration has not
been disrupted for over 100 years. We should no longer accept the
rapid plasma fluctuations of IV bolus opioid administration as the
status quo, as it impacts the patient's hemodynamic status and
requires repeated redosing which ultimately results in higher
overall opioid exposure," commented Dr. Pamela Palmer, AcelRx Chief Medical Officer and
co-founder. "DSUVIA for the first time offers a unique
pharmacokinetic profile for an opioid in the perioperative setting
and other medically supervised settings. We expect this study
to be one of several upcoming datasets to support the broad
acceptance of DSUVIA as an alternative to IV opioids."
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, 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 in June
2018 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 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. AcelRx 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 our
expectations for upcoming datasets to support the broad acceptance
of DSUVIA as an alternative to IV opioids. 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 financial trends, 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, including the
risk that upcoming datasets are not published. Although it is not
possible to predict or identify all such risks and uncertainties,
they may include, but are not limited to, those described 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). 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. 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 events or circumstances after
the date hereof, or to reflect the occurrence of unanticipated
events.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-announces-publication-of-clinical-data-on-reduced-opioid-use-and-reduced-time-in-the-postanesthesia-care-unit-pacu-following-preoperative-administration-of-dsuvia-301114637.html
SOURCE AcelRx Pharmaceuticals, Inc.