SAN MATEO, Calif.SAN MATEO, CA -  (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 Statesthe United States," is lead authored by Dr. David BoldtDavid Boldt, and published in the journal Renal Failure.  Dr. Boldt is an Associate Professor at the University of California, Los Angeles School of Medicine,University of California 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. BoldtDr. 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. BoldtDr. Boldt, are consultants for AcelRx but were not paid for their contributions to this manuscript.