Use of CRRT increased during COVID and
remained at these higher utilization levels
Study results demonstrate challenges
physicians have with heparin and citrate, the two currently
available CRRT anticoagulants
SAN
MATEO, Calif., Dec. 12,
2023 /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 quantitative market research study evaluating current U.S.
physician anticoagulation use during continuous renal replacement
therapy (CRRT) in patients with acute kidney injury in the
intensive care unit. The only FDA-approved anticoagulant for
dialysis circuits is heparin, which has a half-life of 1-3 hours.
Heparin is therefore classified as a "systemic" anticoagulant, as
it circulates back into the patient from the dialysis circuit,
resulting in anticoagulation of the patient, which is often
dangerous. The FDA has given an Emergency Use Authorization (EUA)
to citrate, which is classified as a "regional" anticoagulant, as
its effect is reversed with a calcium infusion that is administered
to the patient, therefore limiting its anticoagulant effect to the
circuit.
The publication, entitled "Anticoagulation Practices for
Continuous Renal Replacement Therapy: A Survey of Physicians from
the United States," is lead
authored by Dr. David Boldt, and
published in the journal Renal Failure. Dr. Boldt is
an Associate Professor at the University of
California, Los Angeles School of Medicine, Critical Care
Intensivist and Division Chief of Trauma and Adult Multi-Specialty
Anesthesiology. In the study, a total of 150 U.S. board-certified
physicians consisting of critical care medicine specialists (n=80)
and nephrologists (n=70) who specialize in CRRT were surveyed by
MedSurvey from November to December
2022 regarding their current CRRT anticoagulation
practices.
This study resulted in a number of key findings:
- CRRT machine use increased by approximately 30% from
pre-pandemic era to late 2022.
- On average, physicians use heparin in the CRRT circuit for 43%
of patients, with citrate being used in 28% of patients and no
anticoagulation used in 29% of patients.
- The top reason for use of heparin is that it is readily
available, but concerns with heparin included systemic bleeding and
heparin-induced thrombocytopenia, which were ranked 3.5 and 3.4
respectively, on a 1-5 scale of "not challenging" to "very
challenging".
- Hypocalcemia (52% of physicians) and citrate safety (42% of
physicians) were ranked as the top two reasons for not using
citrate in heparin-intolerant patients. Physicians who do use
citrate reported that hypocalcemia occurs in 37% of patients.
- When no anticoagulation is used in the CRRT circuit, 84% of
physicians stated filter clogging was a problem and almost a
quarter of the physicians stated an increase in transfusions was
required as a result.
Study limitations include that the study was an online survey;
however, physicians had to pass eight screening questions to ensure
they were board-certified in critical care medicine or nephrology,
worked in an ICU, and were familiar with the protocols and
logistics of CRRT use in their hospital.
"It is clear from this study that physicians in charge of CRRT
at their institutions are not completely satisfied with the
currently available anticoagulants, heparin and citrate, for use in
the dialysis circuit," stated Dr. Pamela Palmer, AcelRx Chief
Medical Officer and co-founder. "Niyad as a potentially new
regional anticoagulant for patients who cannot tolerate heparin
could provide a meaningful improvement to the current standard of
care in this field. Allowing physicians to avoid the complexities
associated with citrate and reducing the number of patients who
receive no anticoagulation by offering a new alternative can
hopefully improve the quality of CRRT for these very fragile
patients."
Dr. Boldt states, "We really don't have any great choices as it
relates to CRRT anticoagulation, which is why I am excited about
the potential approval of Niyad as a new anticoagulant option.
Nafamostat's ultra short half-life of 8 minutes and its limited
systemic effect could really change how we approach anticoagulation
of CRRT circuits. Heparin is fraught with potentially significant,
and often life-threatening, complications such as systemic bleeding
and heparin-induced thrombocytopenia, as well as heparin
resistance, all of which make using heparin challenging in many
patients." Dr. Boldt continues, "While citrate avoids the risk of
systemic bleeding, its complicated administration protocol,
requirement for a calcium infusion, frequent testing of calcium
levels, and citrate toxicity risks can lead many clinicians to
avoid its use altogether."
AcelRx provided funding to conduct the study. Some of the
authors, including Dr. Boldt, are consultants for AcelRx but were
not paid for their contributions to this manuscript.
About AcelRx Pharmaceuticals
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 lead product candidate, 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. AcelRx is also developing two
pre-filled syringes in-licensed from its partner Aguettant:
Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled
phenylephrine syringe. This release is intended for investors only.
For additional information about AcelRx, please visit
www.acelrx.com.
About Nafamostat
Nafamostat is a broad spectrum, synthetic serine protease
inhibitor with anticoagulant, anti-inflammatory 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.
Forward-looking statements
This press release contains forward-looking statements based
upon AcelRx's current expectations. These and any other
forward-looking statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
These statements may be identified by the use of forward-looking
terminology such as "potential", "believe", "expect", "expects",
"expected", "anticipate", "hopefully", "upcoming", "may",
"will", "enable", "should", "seek", "approximately", "intends",
"intended", "plans", "planned", "planning", "estimates",
"benefits", or the negative of these words or other comparable
terminology. The discussion of strategy, plans or intentions may
also include forward-looking statements, which are predictions,
projections and other statements about future events that are based
on current expectations and assumptions. These forward-looking
statements involve risks and uncertainties that could cause actual
results to differ materially from those projected, anticipated or
implied by such statements, including: (i) risks relating to
AcelRx's product development activities and ongoing commercial
business operations; (ii) risks related to the ability of AcelRx
and its business partners to implement development plans, launch
plans, forecasts and other business expectations; (iii) risks
related to unexpected variations in market growth and demand for
AcelRx's commercial and developmental products and technologies;
(iv) risks related to AcelRx's liquidity and its ability to
maintain capital resources sufficient to conduct the required
clinical studies; (v) AcelRx's ability to retain its listing on the
Nasdaq exchange; and (vi) risks relating to AcelRx's ability to
obtain regulatory approvals for its developmental product
candidates. Although it is not possible to predict or identify all
such risks and uncertainties, they may include, but are not limited
to, those described under the caption "Risk Factors" and elsewhere
in AcelRx's annual, quarterly and current reports (i.e., Form 10-K,
Form 10-Q and Form 8-K) as filed or furnished with
the Securities and Exchange Commission (SEC) and any
subsequent public filings. You are cautioned not to place undue
reliance on any such forward-looking statements, which speak only
as of the date such statements were first made. To the degree
financial information is included in this press release, it is in
summary form only and must be considered in the context of the full
details provided in AcelRx's most recent annual, quarterly or
current report as filed or furnished with the SEC.
AcelRx's SEC reports are available
at www.acelrx.com under the "Investors" tab. Except to
the extent required by law, AcelRx undertakes no obligation to
publicly release the result of any revisions to these
forward-looking statements to reflect new information, events or
circumstances after the date hereof, or to reflect the occurrence
of unanticipated events.
For additional information about AcelRx, please visit
www.acelrx.com.
This release is intended for investors only.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-announces-publication-of-study-evaluating-anticoagulation-practices-for-continuous-renal-replacement-therapy--in-the-united-states-302012467.html
SOURCE AcelRx Pharmaceuticals, Inc.