AcelRx Announces an Investigator-Initiated Study of DSUVIA® for Use in Same-Day Total Joint Replacement
May 06, 2021 at 06:30 am EDT
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AcelRx Pharmaceuticals, Inc. (AcelRx) announced an investigator-initiated study to be conducted at The CORE Institute Specialty Hospital in Phoenix, Arizona by the Musculoskeletal Orthopedic Research and Education (MORE) Foundation evaluating the perioperative use of DSUVIA (sufentanil sublingual tablet 30 mcg) for patients undergoing hip or knee replacement as a same-day surgical procedure. MORE Foundation is a non-profit organization dedicated to studying all musculoskeletal conditions and the leading causes of disability and chronic pain. The principal investigator, Dr. John Thompson, is an orthopedic surgeon specializing in hip and knee replacement at The CORE Institute, a nationally recognized orthopedic practice setting the standard in musculoskeletal care through the delivery of evidence-based medicine and standardized clinical protocols. The CORE Institute Specialty Hospital recently received the 2021 America's 100 Best Hospitals for Joint Replacement Award for superior clinical outcomes in knee and hip replacement. The study is a prospective, randomized, patient-blinded, continuous case series that will evaluate the efficacy and safety of DSUVIA (sufentanil) for perioperative management of surgical pain in 100 patients undergoing same-day hip or knee joint replacement. The length of stay of patients receiving one dose of DSUVIA (sufentanil) preoperatively and one dose postoperatively in the postanesthesia care unit (PACU) is the primary endpoint and will be compared to patients receiving standard of care perioperative pain management. Secondary endpoints include average total morphine milligram equivalents dosed per patient, ability to complete physical therapy prior to discharge from the PACU, and overall cost of the stay.
Talphera, Inc., formerly AcelRx Pharmaceuticals, Inc., is a specialty pharmaceutical company. The Company is focused on the development and commercialization of therapies for use in medically supervised settings. The Company's nafamostat product candidates include Niyad and LTX-608. Niyad is focused on developing regional anticoagulants for injection into the extracorporeal circuit, such as the dialysis circuit during continuous renal replacement therapy (CRRT) for acute kidney injury (AKI) patients in the hospital, and for chronic kidney disease patients undergoing intermittent hemodialysis (IHD) in dialysis centers. LTX-608 is nafamostat formulation for direct intravenous (IV) infusion that shall 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. The Company is also engaged in developing two pre-filled syringes, namely Fedsyra and PFS-02.