AcelRx Announces an Investigator-Initiated Study of DSUVIA® in the Emergency Department for Patients with Sickle Cell Disease
HAYWARD, Calif., May 20, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced an investigator-initiated study to be conducted at Tampa General Hospital to evaluate the use of DSUVIA for patients with sickle cell disease presenting to the emergency department (ED) with painful vaso-occlusive crisis (VOC).
The study will enroll 100 patients presenting to the emergency department with VOC who are administered DSUVIA to manage the patients' moderate-to-severe acute pain until an IV line can be accessed. The IV line is important for hydration, high-dose IV opioid administration as these patients are often opioid-tolerant, as well as administration of other parenteral medications. Endpoints will include the time from arrival in the ED to first analgesic medication, ED length of stay, hospital admission rates, patient and clinician satisfaction, and adverse events. Patients administered DSUVIA will be compared to a historical ED control group who received routine pain management for VOC, including waiting until IV access is established before opioids are administered.
The study's principal investigator is Jason Wilson, MD, MA, CPHQ, FACEP. Dr. Wilson is an attending emergency medicine physician serving as Director of the ED Clinical Decision Unit, Tampa General Hospital at TeamHealth. In this capacity, he is responsible for developing and implementing protocols and patient pathways that improve throughput metrics and quality of care for patients. Dr. Wilson also serves as an Associate Professor and core faculty for the University of South Florida College of Medicine, Division of Emergency Medicine, and as Research Director of the University of South Florida, Emergency Medicine Residency Program, Tampa General Hospital.
"I see patients with sickle cell disease presenting with VOC every day in the ED. I am working to establish trust with these patients who have often experienced a lifetime of under-controlled pain and frequent visits and readmissions to the hospital," states Dr. Wilson. "Often these patients have already tried oral medications at home and present to us with severe acute pain. Unfortunately, IV access can be difficult to obtain in these patients and often requires ultrasound-guided IV placement, which means it may take hours before patients receive strong opioid analgesics, which are the mainstay of treatment for their severe pain. Oral pain medication does not serve as a sufficient bridge and another option is needed. Our early experience with DSUVIA indicates that this rapid-onset sublingual option may be an effective analgesic bridge that manages pain while practitioners establish IV access in these opioid-tolerant patients, allowing early and proactive pain management in patients with VOC which could build trust in the patient encounter and avoid admissions," continued Dr. Wilson.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, please visit www.DSUVIA.com.
About AcelRx Pharmaceuticals, Inc.
For additional information about AcelRx, please visit www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.
Company Codes: NASDAQ-NMS:ACRX