Study found that SST lowered the opioid dose
required by patients in the post-anesthesia care unit (PACU) by
more than five-fold compared to standard intravenous opioid
administration
HAYWARD,
Calif., May 10, 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 clinical data from an
investigator-initiated trial in patients undergoing lengthy plastic
surgery procedures performed under general anesthesia, where use of
a single sufentanil sublingual tablet 30 mcg (SST; DSUVIA®) in
conjunction with intravenous (IV) opioids was able to dramatically
reduce postoperative opioid requirements compared to an equivalent
dose of opioids administered only via the IV route.
The article entitled, "Sufentanil sublingual tablet reduces
postoperative opioid use following outpatient plastic surgery," was
published by the Aesthetic Surgery Journal Open Forum as an
original article and was authored by Dr. Hisham Seify from Newport Plastic Surgery in
Newport Beach, California. The
study was a retrospective chart review of patients (n=61) receiving
a single 30 mcg SST 30 minutes prior to surgery (for shorter
procedures) or 45 minutes prior to surgical extubation (longer
procedures). A control group (n=32) underwent similar surgical
procedures utilizing standard IV opioid treatment without SST.
Outcome measures included PACU opioid use, adverse events, and
recovery time compared to traditional IV opioid drug
regimens.
The demographics were similar between the two groups with over
90% of patients being female. Average age was 46.1 ± 13.4 in the
SST group and 44.1 ± 9.6 in the control group. The most
common surgical procedures performed in both groups were bilateral
breast augmentations or reductions, often combined with an
additional procedure (e.g., liposuction and/or abdominoplasty).
There was a trend for procedure duration to be slightly longer for
controls (3 hours and 12 minutes) than for the SST group (2 hours
and 40 minutes); (P=0.10). As a result, duration of surgery was
used as a covariate for subsequent analyses comparing morphine
milligram equivalent (MME) opioid administration between the SST
and control groups.
Key findings from the study included:
- 92% of SST patients received the dose prior to extubation due
to the large proportion of lengthy cases that were performed.
- Almost all control patients (90.6%) required rescue opioids
during recovery in the PACU as compared to significantly fewer SST
patients (16.4%); (P<0.001).
- While there was no difference in total intraoperative opioid
administration between the groups, the average postoperative MME in
the PACU was 3.60 ± 2.65 mg for the control group versus over
5-fold lower (0.64 ± 2.31 mg) for the SST group (P<0.001).
- All patients received prophylactic antiemetics, however, 9.4%
of patients in the control group required additional antiemetics
due to nausea in the PACU, whereas only 1.6% of SST patients
required an antiemetic in the PACU.
- Time to discharge was similar, being slightly under an hour in
both groups, and not driven by assessment of pain management and/or
adverse events. Instead, the actual discharge time was based on
standard nursing routines and availability of patient
transport.
Study limitations include that it was a chart review and not a
prospectively designed, randomized study. In addition, no pain
scores or readiness for discharge assessments were performed, which
could have been used to assess the potential of SST to facilitate a
timelier discharge.
"The vast majority of cosmetic surgical cases are outpatient
procedures and patients who are having three- to four-hour
surgeries must quickly recover in order to be discharged home,"
said Dr. Hisham Seify. "Replacing
the last intraoperative dose of IV opioids with an equivalent dose
of SST dramatically decreased the need for recovery opioids in the
PACU, as shown by our study results. Since our PACU protocol was
standardized, we didn't observe a more rapid time to discharge in
this retrospective study. However, based on these findings, we now
know to have our nurses expedite the discharge paperwork for
SST-treated patients and tell family members to be ready sooner to
drive the patient home," continued Dr. Seify.
"Multiple perioperative studies have now been published
demonstrating the ability of DSUVIA® to dramatically reduce opioid
requirements in the postoperative period compared to standard IV
opioids," stated Dr. Pamela Palmer, AcelRx Chief Medical
Officer and co-founder. "Based on standard clinical guidelines,
every time an IV opioid is administered in the PACU, the discharge
clock is restarted. We also know that increased opioid
administration increases the risk of nausea and vomiting, which is
one of the top reasons for delayed post-surgical discharge. The
adoption of DSUVIA is gaining momentum as physicians are seeing
these documented clinical advantages," continued Dr. Palmer.
Note of disclosure: Dr. Seify is a paid consultant for AcelRx
and the company provided funding for this study as an
investigator-initiated trial.
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), 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, including the following: 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; two pre-filled, ready-to-use syringes of ephedrine and
phenylephrine licensed for the U.S. from Aguettant; Niyad™
(nafamostat), a regional anticoagulant for the extracorporeal
circuit; and, LTX-608 for the potential treatment of COVID-19,
disseminated intravascular coagulation, acute respiratory distress
syndrome and acute pancreatitis. DZUVEO and Zalviso are both
approved products in Europe. For
additional information about AcelRx, please visit
www.acelrx.com.
For additional information about AcelRx, please visit
www.acelrx.com.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-announces-publication-of-results-from-an-investigator-initiated-trial-on-sufentanil-sublingual-tablet-sst-compared-to-standard-intravenous-opioids-during-plastic-surgery-procedures-performed-under-general--301543161.html
SOURCE AcelRx Pharmaceuticals, Inc.