Study results demonstrate that nafamostat had
similar efficacy as citrate, while providing lower toxicity and
lower costs to the hospital over standard citrate
anticoagulation.
HAYWARD,
Calif., March 29, 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 comparative data between two
different dialysis circuit anticoagulants in pediatric patients
undergoing continuous renal replacement therapy (CRRT).
Nafamostat is a commonly used dialysis anticoagulant in
South Korea and Japan where it has been approved for this
indication for the past few decades, whereas regional citrate
anticoagulation (RCA) is commonly used in the EU and US (under an
Emergency Use Authorization), since nafamostat is not available
commercially. RCA has the risk of citrate toxicity and involves a
complex, labor-intensive dosing regimen and therefore there is an
interest outside of Korea and Japan to develop nafamostat for dialysis
circuit anticoagulation. AcelRx has recently acquired the Lowell
Therapeutics nafamostat asset to develop it for use in any
extracorporeal circuit, including the dialysis circuit.
The article entitled "Comparison of Nafamostat Mesilate to
Citrate Anticoagulation in Pediatric Continuous Kidney Replacement
Therapy" was senior authored by Stuart
Goldstein, MD, FAAP, FASN, FNKF and published in the journal
Pediatric Nephrology. Dr. Goldstein holds the Clark D. West
Endowed Chair and is Professor and Director of the Center for Acute
Care Nephrology at the Cincinnati Children's Hospital Medical
Center. While this study focuses on pediatric patients, the
standard of care is similar between adult and pediatric
populations. The study was a retrospective comparison of pediatric
patients undergoing CRRT (also known as CKRT) using nafamostat in a
single center in Japan versus
citrate in a single center in the US. Outcome measures included
dialysis filter lifespan, incidence of bleeding and drug toxicity,
and a cost comparison between the two anticoagulation methods was
performed.
A total of 158 patients were evaluated at both sites,
demonstrating a number of key findings:
- Median filter life was longer for nafamostat but once corrected
for key variables, the two groups appeared similar regarding this
outcome
- No differences in major or minor bleeding rates were
observed
- Citrate toxicity occurred in 14% of patients, whereas no
toxicity events with nafamostat occurred
- Citrate anticoagulation is over 3 times the cost of
nafamostat
Study limitations include that dialysis protocols varied to some
degree between sites, the nafamostat patients on average were
younger and smaller, and half the nafamostat patients were
concomitantly undergoing plasmapheresis.
"Currently in the US, the safest option for regional
anticoagulation in CRRT is the use of citrate," said Dr. Goldstein.
"These data demonstrate that both nafamostat and regional citrate
can provide acceptable CRRT filter life with a low risk of bleeding
events in patients who require CRRT. Nafamostat has the added
advantages of a simpler administration regimen for ICU staff, less
risk of electrolyte derangement, no dependence on IV calcium or
other reversal agents, as well as overall lowered costs to the
hospital."
"AcelRx looks forward to the opportunity to develop nafamostat
as a regional anticoagulant for CRRT in patients with acute renal
failure," stated Dr. Pamela Palmer, AcelRx Chief Medical
Officer and co-founder. "Avoiding the risk of citrate toxicity and
simplifying the anticoagulation of the dialysis circuit may allow
nafamostat to become the preferred method for providing
anticoagulation for CRRT once approved for use."
Dr. Mai Miyaji, the study's lead
author, was a paid consultant for Lowell Therapeutics but was not
compensated for this study. Neither Lowell nor AcelRx provided
funding for the conduct of the study, nor did they have any input
into the design of the study. Dr. Goldstein is not a paid
consultant for Lowell or AcelRx.
About nafamostat mesylate (or mesilate)
Nafamostat is
a broad spectrum, synthetic serine protease inhibitor with
anticoagulant, anti-inflamatory and potential anti-viral
activities. Niyad™ is a lyophilized formulation of nafamostat and
is currently being studied under an investigational device
exemption, or IDE, as an anticoagulant for the extracorporeal
circuit, and has received Breakthrough Device Designation Status
from the FDA. LTX-608 is a proprietary nafamostat formulation for
direct IV infusion that will be investigated and developed as a
potential anti-viral for the treatment of COVID, acute respiratory
distress syndrome (ARDS), disseminated intravascular coagulation
(DIC) and acute pancreatitis.
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;
Niyad™(nafamostat mesylate), 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.
This release is intended for investors only.
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SOURCE AcelRx Pharmaceuticals, Inc.