REDWOOD CITY, Calif.,
March 25, 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 a pooled
analysis of Phase 3 data on the use of DSUVIA for acute pain
management in the postoperative and emergency department settings
in the Journal of Pain Research.
The article entitled "Patient and Healthcare Professional
Satisfaction Ratings and Safety Profile of Sufentanil Sublingual
Tablets for Treatment of Acute Pain: A Pooled Demographic Analysis"
by lead author David Leiman, MD,
University of Texas at Houston
Department of Surgery and HD Research, Houston TX, reported high ratings for global
assessment of the method of pain control and a well-tolerated
safety profile for all demographic subgroups following the
dosing of sufentanil sublingual tablet 30 mcg (DSUVIA) in
postoperative and emergency department patients.
The global satisfaction analysis included a total of 283
patients who had completed the assessments as well as their
healthcare professionals who had dosed DSUVIA in the clinical
trials. The patient global assessment (PGA) and the healthcare
professional global assessment (HPGA) scale is a 4-point scale of
"poor", "fair", "good", or "excellent" for the method of pain
control and these scores were assessed across the patient
demographic subgroups of age, body-mass index (BMI), sex and race.
Adverse events across these same demographic
subpopulations were also assessed. Key findings included the
following:
- The highest percent of excellent scores across all evaluations
was for the HPGA in older patients (≥ 65 years), with 61% of
healthcare professionals rating pain control in these older
patients as "excellent"; there were no statistical differences
across older versus younger patients for either PGA or HPGA.
- High ratings by both low (< 30 kg/m2) and high
BMI (≥ 30 kg/m2) patients on the PGA were observed
with 86% and 85%, respectively, rating "good" or "excellent" on the
PGA; similar ratings were seen with the HPGA for these subgroups
and no statistical differences were observed between the
groups.
- Male and female patients had high ratings on both the PGA and
HPGA, with HPGA scores statistically higher for male patients over
female patients (p=0.023), while PGA scores were similar and not
statistically different.
- There were no statistical differences among races for either
the PGA or HPGA with each of these subpopulations scoring high
percentages of "good" or "excellent" ratings.
DSUVIA was well tolerated throughout the Phase 3 studies with
68% of the 323 total patients evaluated not experiencing any
DSUVIA-related adverse events. Adverse events occurring in
≥ 2% of the patients were nausea (22.9%), headache (5.0%),
dizziness (4.0%) and vomiting (3.1%). Importantly, the adverse
events of decreased oxygen saturation and somnolence were low,
occurring in 1.5% and 1.2% of the patients, respectively. Study
limitations included a higher enrollment of younger compared to
older patients, and opioid-tolerant patients were excluded.
"The results from this pooled analysis of the DSUVIA Phase 3
trials mirror the impressive clinical outcomes that I observed
during dosing of DSUVIA in these clinical trial patients as well as
patients in my current anesthesia practice," said Dr. Leiman. "The
rapid onset and analgesic effectiveness combined with DSUVIA being
well tolerated throughout the Phase 3 program, with low respiratory
and CNS side-effect rates, makes using DSUVIA an appropriate choice
in my patients. The older patients obtaining the highest healthcare
professional rating in the "excellent" category does not surprise
me as DSUVIA's low peak plasma concentration and high therapeutic
index are optimally suited to this patient population," continued
Dr. Leiman.
"The consistency of analgesia across the demographic subgroups
was notable, especially given the single 30-mcg dose for all
patients," said Dr. Pamela Palmer, AcelRx Chief Medical
Officer and co-founder. "The patients, whether old or young, obese
or non-obese, and regardless of sex or race, reported overall high
ratings for the global assessment of pain control and their
healthcare professionals also rated these patients with high scores
among the different subgroups."
These Phase 3 studies were funded by AcelRx and the Clinical and
Rehabilitative Medicine Research Program (CRMRP) of the US Army
Medical Research and Materiel Command (USAMRMC). Dr. Leiman is a
paid consultant of AcelRx.
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.
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