HAYWARD, Calif., Dec. 15, 2021 /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 real-world data in patients
undergoing total hip or total knee replacement showing decreased
hospital length of stay and decreased opioid utilization following
administration of sublingual sufentanil to manage acute pain
compared to standard IV opioids. The article was published in the
Journal of Orthopaedic Experience and Innovation.
The article 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" 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 sufentanil sublingual
tablet 30 mcg (SST; DSUVIA®) in the perioperative period and
compared these patients to matched historical control patients
receiving standard IV opioids. The outcomes assessed were the
overall amount of opioids administered throughout the hospital stay
(calculated as morphine milligram equivalents), the patient length
of stay, and patient disposition at discharge.
A total of 110 patients were evaluated, with 53 patients
prospectively treated with SST and 57 patients in the historical
comparator group. Patient demographics, anesthesia techniques and
type of surgery were similar between the groups. Patients in both
groups averaged over 65 years of age and almost 50% had severe
systemic disease, defined as Physical Status III by the American
Society of Anesthesiologists.
Key findings included the following:
- The SST group utilized approximately 30% less total morphine
milligram equivalents throughout their stay (17.8 ± 2.4 vs 25.0 ±
3.3 for control patients [P < .05]).
- Hospital length of stay was approximately 30% shorter for the
SST group (0.87 ± 0.12 vs 1.23 ± 0.16 nights [P < .05]).
- In the control group, 9 patients (15.8%) were discharged to a
skilled nursing facility compared to none in the SST group (P <
.01). Their average hospital length of stay was 3.3 ± 0.8 nights
prior to discharge to the facility and the average morphine
milligram equivalent was 49.1 ± 14.6, almost 3-fold higher than the
SST group.
Study limitations include that the control group was a
historical cohort, however, both groups received surgery during the
COVID pandemic of Summer 2020 and anesthetic techniques, analgesic
protocols and discharge criteria were identical between the two
groups with the exception of the dosing of SST. Another limitation
is that only a single SST dose was evaluated, and it is unclear if
additional reductions in opioid utilization might be attained if a
second or third dose was utilized over the duration of the
patient's postoperative stay.
"The results from this study showing less overall opioid
utilization and more rapid discharge following joint replacement
are impressive, especially given the fact that only a single dose
of DSUVIA was administered. We used to routinely get calls from the
floor nurses the day of surgery when the spinal anesthetic had worn
off with patients having rebound pain, but those calls immediately
diminished following the adoption of DSUVIA into our current
practice," states lead author Dr. Wiesner. "The joint replacement
patients are older and have many comorbidities, therefore it is
advantageous to utilize an opioid that not only provides rapid
analgesia with initial dosing, but also has a low peak plasma
concentration, a high therapeutic index, and a 13-hour terminal
half-life allowing lower postoperative opioid requirements and a
faster discharge," continues Dr. Wiesner.
"While Dr. Wiesner and his colleagues practice state-of-the-art
multimodal analgesia in their total joint program, by using SST
they were able to even further reduce their reliance on IV opioids
in the perioperative setting" said Dr. Pamela Palmer, AcelRx
Chief Medical Officer and co-founder. "The positive effect this had
on patient length of stay and avoiding discharge to a nursing
facility is an important clinical outcome for this patient
population. Real-world studies continue to show that SST is well
tolerated by the older patient population that generally undergoes
these total joint procedures," states Dr. Palmer.
Dr. Wiesner is not a paid consultant for AcelRx. Dr.
Tvetenstrand is a paid consultant for AcelRx but was not
compensated for this study. AcelRx did not provide funding for the
conduct of the study 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.