AcelRx Pharmaceuticals Announces Publication of Clinical Data Finding Potential Benefits of Nafamostat Compared to Regional Citrate for Anticoagulation of the

Study benefits show that nafamostat experienced similar efficacy as citrate, though supplying reduce toxicity and decrease prices to the clinic over regular citrate anticoagulation.

HAYWARD, Calif., March 29, 2022 /PRNewswire/ — AcelRx Prescribed drugs, Inc. (NASDAQ: ACRX), a specialty pharmaceutical organization focused on the development and commercialization of innovative therapies for use in medically supervised settings, currently announced the publication of comparative information involving two different dialysis circuit anticoagulants in pediatric patients going through steady renal alternative therapy (CRRT). Nafamostat is a frequently made use of dialysis anticoagulant in South Korea and Japan where it has been accepted for this sign for the earlier number of decades, while regional citrate anticoagulation (RCA) is frequently utilized in the EU and US (beneath an Crisis Use Authorization), considering the fact that nafamostat is not readily available commercially. RCA has the threat of citrate toxicity and requires a complicated, labor-intensive dosing regimen and consequently there is an curiosity outdoors of Korea and Japan to establish nafamostat for dialysis circuit anticoagulation. AcelRx has a short while ago acquired the Lowell Therapeutics nafamostat asset to develop it for use in any extracorporeal circuit, like the dialysis circuit.

The posting entitled “Comparison of Nafamostat Mesilate to Citrate Anticoagulation in Pediatric Constant Kidney Replacement Treatment” was senior authored by Stuart Goldstein, MD, FAAP, FASN, FNKF and revealed in the journal Pediatric Nephrology. Dr. Goldstein retains the Clark D. West Endowed Chair and is Professor and Director of the Middle for Acute Care Nephrology at the Cincinnati Children’s Clinic Clinical Center. Whilst this research focuses on pediatric individuals, the normal of treatment is similar in between grownup and pediatric populations. The examine was a retrospective comparison of pediatric clients undergoing CRRT (also known as CKRT) employing nafamostat in a solitary centre in Japan vs . citrate in a single heart in the US. Result actions incorporated dialysis filter lifespan, incidence of bleeding and drug toxicity, and a cost comparison involving the two anticoagulation methods was performed.

A complete of 158 sufferers ended up evaluated at the two websites, demonstrating a range of important findings:

  • Median filter existence was extended for nafamostat but the moment corrected for vital variables, the two groups appeared related about this final result

  • No variations in important or minor bleeding prices had been observed

  • Citrate toxicity transpired in 14% of individuals, while no toxicity activities with nafamostat happened

  • Citrate anticoagulation is around 3 occasions the expense of nafamostat

Review limitations consist of that dialysis protocols various to some diploma involving web pages, the nafamostat clients on typical were younger and more compact, and 50 % the nafamostat people were concomitantly undergoing plasmapheresis.

“Presently in the US, the most secure choice for regional anticoagulation in CRRT is the use of citrate,” stated Dr. Goldstein. “These info demonstrate that both nafamostat and regional citrate can present satisfactory CRRT filter lifestyle with a very low hazard of bleeding functions in individuals who involve CRRT. Nafamostat has the extra rewards of a more simple administration program for ICU staff members, much less hazard of electrolyte derangement, no dependence on IV calcium or other reversal brokers, as nicely as all round decreased expenditures to the hospital.”

“AcelRx appears to be like forward to the opportunity to develop nafamostat as a regional anticoagulant for CRRT in patients with acute renal failure,” stated Dr. Pamela Palmer, AcelRx Main Health care Officer and co-founder. “Staying away from the risk of citrate toxicity and simplifying the anticoagulation of the dialysis circuit might allow nafamostat to turn into the chosen system for offering anticoagulation for CRRT when permitted for use.”

Dr. Mai Miyaji, the study’s lead writer, was a compensated expert for Lowell Therapeutics but was not compensated for this research. Neither Lowell nor AcelRx furnished funding for the perform of the examine, nor did they have any enter into the style of the research. Dr. Goldstein is not a paid expert for Lowell or AcelRx.

About nafamostat mesylate (or mesilate)
Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflamatory and possible anti-viral functions. Niyad™ is a lyophilized formulation of nafamostat and is presently becoming studied beneath an investigational system exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has gained Breakthrough Product Designation Position from the Food and drug administration. LTX-608 is a proprietary nafamostat formulation for immediate IV infusion that will be investigated and designed as a opportunity anti-viral for the cure of COVID, acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC) and acute pancreatitis.

About AcelRx Prescribed drugs, Inc.
AcelRx Prescribed drugs, Inc. is a specialty pharmaceutical company focused on the growth and commercialization of modern therapies for use in medically supervised configurations. AcelRx’s proprietary, non-invasive sublingual formulation technological innovation delivers sufentanil with consistent pharmacokinetic profiles. The Company has one particular accredited item in the U.S., DSUVIA® (sufentanil sublingual tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the administration of acute discomfort intense more than enough to require an opioid analgesic for grownup people in certified medically supervised health care settings, and many product candidates. The item candidates consist of Zalviso® (sufentanil sublingual tablet procedure, SST method, 15 mcg), an investigational solution in the U.S. staying designed as an innovatively created patient-managed analgesia (PCA) procedure for reduction of reasonable-to-critical acute pain in medically supervised options, and two pre-filled, completely ready-to-use syringes of ephedrine and phenylephrine certified for the U.S. from Aguettant Niyad™(nafamostat mesylate), a regional anticoagulant for the extracorporeal circuit, and LTX-608, for the probable therapy of COVID-19, disseminated intravascular coagulation, acute respiratory distress syndrome and acute pancreatitis. DZUVEO and Zalviso are equally approved solutions in Europe.

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AcelRx Pharmaceuticals Announces Publication of Clinical Data Finding Potential Benefits of Nafamostat Compared to Regional Citrate for Anticoagulation of the

AcelRx brand. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Prescribed drugs, Inc.)



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