AcelRx Pharmaceuticals Announces Release of Clinical Data on Potential Benefits of Nafamostat Over Regional Citrate for Dialysis Circuit Anticoagulation

Study results demonstrate that nafamostat had similar efficacy to citrate, while offering lower toxicity and lower costs to the hospital compared to standard citrate anticoagulation.

HAYWARD, Calif., March 29, 2022 /PRNewswire/ — AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on developing and commercializing innovative therapies for use in medically supervised settings, today announced the release of comparative data between two different dialysis circuit anticoagulants in pediatric patients on continuous renal replacement therapy (CRRT). Nafamostat is a dialysis anticoagulant commonly used in South Korea and Japan where it has been approved for this indication for the last few decades, whereas regional citrate anticoagulation (RCA) is commonly used in the EU and US (under emergency use authorization), since nafamostat is not commercially available. RCA poses a risk of citrate toxicity and involves a complex and labor-intensive dosing regimen. So there is interest outside of Korea and Japan develop nafamostat for the anticoagulation of dialysis circuits. AcelRx recently acquired the nafamostat asset from Lowell Therapeutics 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 written by Stuart GoldsteinMD, FAAP, FASN, FNKF and published in the journal Pediatric nephrology. Dr. Goldstein is the Clark D. West Endowed Professor and Professor and Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center. Although 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 at a single center in Japan versus citrate at a single center in the United States. Outcomes included dialysis filter life, bleeding incidence, and drug toxicity, and a cost comparison between the two anticoagulation methods was performed.

A total of 158 patients were assessed across the two sites, demonstrating a number of key findings:

  • Median filter life was longer for nafamostat, but when corrected for key variables, the two groups appeared similar with respect to this outcome

  • No difference in major or minor bleeding rates was observed

  • Citrate toxicity occurred in 14% of patients, while no toxicity events with nafamostat occurred

  • Citrate anticoagulation costs more than 3 times the cost of nafamostat

Limitations of the study include that dialysis protocols varied to some extent between sites, nafamostat patients were on average younger and shorter, and half of nafamostat patients simultaneously underwent plasmapheresis.

“Currently in the United States, the safest option for regional anticoagulation in CRRT is the use of citrate,” Dr. Goldstein said. “These data demonstrate that nafamostat and regional citrate can provide acceptable CRRT filter life with a low risk of bleeding events in patients requiring CRRT. Nafamostat has the added benefits of a longer dosing regimen simpler for ICU staff, less risk of electrolyte disturbance, reliance on IV calcium or other reversal agents, and reduced overall 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,” said Dr. Pamela Palmer, Chief Medical Officer and Co-Founder of AcelRx. “Avoiding the risk of citrate toxicity and simplifying anticoagulation of the dialysis circuit may allow nafamostat to become the preferred method for providing anticoagulation for CRRT once approved for use.”

dr. May Miyaji, the lead author of the study, was a paid consultant for Lowell Therapeutics but was not paid for this study. Neither Lowell nor AcelRx provided funding to conduct the study, nor did they contribute to the study design. Dr. Goldstein is not a paid consultant for Lowell or AcelRx.

About nafamostat mesylate (or mesilate)
Nafamostat is a synthetic, broad-spectrum serine protease inhibitor with potential anticoagulant, anti-inflammatory, and antiviral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being investigated under an Investigational Device Exemption, or IDE, as an anticoagulant for extracorporeal circuitry, and has been awarded Breakthrough Device Designation status from the FDA. LTX-608 is a proprietary formulation of nafamostat for direct IV infusion that will be studied and developed as a potential antiviral 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 environments. AcelRx’s proprietary non-invasive sublingual formulation technology provides sufentanil with consistent pharmacokinetic profiles. The company has an approved product in the United States, 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 in adult patients in certified healthcare facilities under medical supervision, and several product candidates. Product candidates include Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product under development in the United States as an innovative patient-controlled analgesia (PCA) system for the reduction of acute moderate to severe in medically supervised environments, and two of the pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the United States 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. Both DZUVEO and Zalviso are approved products in Europe.

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AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)



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Jacob L. Thornton