HAYWARD, Calif., Jan. 12, 2022 /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 an editorial regarding the use
of sufentanil sublingual tablet (SST; DSUVIA®) in total joint
replacement surgery by Dr. Scott
Sigman in the Journal of Orthopaedic Experience and
Innovation. Dr. Sigman is a board-certified orthopedic surgeon
at Orthopedic Surgical Associates of Lowell, the former Chief of Orthopedics at
Lowell General Hospital in Lowell
Massachusetts, and an internationally recognized leader in
opioid-sparing orthopedic surgery.
Dr. Sigman's editorial, entitled "Opioid Stewardship: Is There a
"Better" Opioid?," reflects his expert opinion on the recently
published article in the same journal entitled "Reduced opioid use
and hospital stay in patients undergoing total knee or total hip
arthroplasty when treated with sublingual sufentanil compared with
standard analgesic care" which was co-authored by Dr. Lawrence Wiesner and Dr. Christian Tvetenstrand from the United Health
Services Orthopedic Center in Vestal, New
York and Southern Tier Surgical Clinic in Johnson City, New York. The study
prospectively evaluated patients who were administered a single SST
30 mcg in the perioperative period and compared their length of
stay and overall opioid use to matched historical control patients
receiving standard IV opioids.
In the editorial, Dr. Sigman emphasizes the importance of
minimizing opioid exposure to the patient as part of good Opioid
Stewardship practices, and that physicians using Enhanced Recovery
After Surgery (ERAS) protocols must consider whether there is an
opportunity to further reduce perioperative opioid exposure by the
selection of the opioid analgesic they utilize. Dr. Sigman
highlights the results from the Dr. Wiesner study, which
demonstrated an approximately 30% reduction in both overall opioid
use and hospital length of stay in the SST-treated patients
compared to the IV opioid group, as well as a reduction in the SST
group of the number of patients requiring discharge to a skilled
nursing facility instead of being discharged to home.
As highlighted in the editorial, Dr. Sigman believes the results
of this study identify SST as a viable option for the advancement
of the ideals of Opioid Stewardship with the potential to reduce
opioid utilization, which could potentially reduce opioid-related
adverse events, length of stay, and possibly decrease the risk of
physical dependence and addiction in the postoperative period.
While the study was not double-blinded or placebo-controlled and
the control group was a historical cohort, Dr. Sigman states, "The
fact that the patient selection was not stringent, and that
multiple types of surgeries and anesthetic techniques were
included, may in fact allow a better sense of the utility of SST in
a real-world clinical setting compared to a highly controlled
trial."
"We expect Dr Sigman's commentary on the importance of SST in
reducing the exposure of patients to opioids in the perioperative
setting to resonate with his surgical colleagues given his
international profile as an opioid-sparing surgeon" said
Dr. Pamela Palmer, AcelRx Chief Medical Officer and
co-founder. "His advocacy of SST as a viable option to advance the
ideals of Opioid Stewardship is a notable declaration of the
potential importance of SST in the perioperative setting,"
continued Dr. Palmer.
Dr. Sigman is a paid consultant for AcelRx but was not
compensated for this editorial. Dr. Wiesner is not a paid
consultant for AcelRx. Dr. Tvetenstrand is a paid consultant for
AcelRx but was not compensated for the study that is the subject of
the editorial. AcelRx did not provide funding for the conduct of
the study that is the subject of the editorial but did fund medical
writing support.
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 it will be commercialized by
AcelRx's European partner, Aguettant.
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), 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 several product candidates. The
product candidates include 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, and
two pre-filled, ready-to-use syringes of ephedrine and
phenylephrine licensed for the U.S. from Aguettant. DZUVEO and
Zalviso are both approved products in Europe.
For additional information about AcelRx, please visit
www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.