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
DSUVIA®, known as DZUVEO® in Europe, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe and the Company is currently in discussions with potential European marketing partners.

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.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx’s proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has one approved product in the U.S., 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 for adult patients in certified medically supervised healthcare settings, and one product candidate, Zalviso^® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S., is being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings. DZUVEO and Zalviso are both approved products in Europe.

For additional information about AcelRx, please visit www.acelrx.com.

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to expected commencement of an investigator-initiated study, the scope of the study, expected analysis of clinical data, the potential for DSUVIA to be an effective analgesic bridge for patients with sickle cell disease presenting with VOC and the potential for proactive pain management in patients with VOC to build trust in the patient encounter and avoid admissions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as “believes,” “expects,” “anticipates,” “may,” “will,” “should,” “seeks,” “approximately,” “intends,” “plans,” “estimates,” or the negative of these words or other comparable terminology. The discussion of strategy, plans or intentions may also include forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements. In addition, such risks and uncertainties may include, but are not limited to, those described in the Company’s annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. The Company’s SEC reports are available at www.acelrx.com under the “Investors” tab. Except to the extent required by law, the Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

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SOURCE AcelRx Pharmaceuticals, Inc.