AcelRx Announces an Investigator-Initiated Study of DSUVIA® for Use in Same-Day Total Joint Replacement

HAYWARD, Calif., May 6, 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 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.

"Effective pain management is absolutely critical for patients to be successfully discharged to home the same day as their hip or knee replacement procedure," said Dr. Thompson. "I have begun to order DSUVIA (sufentanil) and have been impressed with its ability to control pain following these procedures while not contributing to mental confusion or sedation, thereby allowing successful discharge to home from the PACU. We are now interested in conducting this prospective study to fully analyze the potential benefits that can be obtained by using DSUVIA (sufentanil) as an alternative to IV opioids in this patient population," continued Dr. Thompson.

"One of the toughest challenges for anesthesiologists is providing effective analgesia allowing same-day discharge following joint replacement while avoiding sedation or confusion in the patient," said Dr. Pamela Palmer, co-founder and Chief Medical Officer of AcelRx. "Patients undergoing these types of procedures are often of an advanced age and the high peak plasma concentrations achieved with standard IV bolus opioids can frequently lead to side effects that can delay discharge. DSUVIA's (sufentanil's) blunted peak plasma concentrations compared to IV bolus administration and lack of cognitive impairment in patients as demonstrated in our Phase 3 study may allow these patients to be more awake and alert in the PACU, thereby facilitating same-day discharge."

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 MORE Foundation
The Musculoskeletal Orthopedic Research and Education (MORE) Foundation is an Arizona non-profit corporation. MORE Foundation pioneers innovative musculoskeletal research programs, provides educational programs for the healthcare community, and conducts charitable assistance programs that enhance access to healthcare for vulnerable populations. MORE's community-focused programs empower individuals to Keep Life in Motion®.

About The CORE Institute
The CORE Institute was founded to fulfill a vision of excellence in patient care encompassing the entire spectrum of orthopedic and neurosciences care. The CORE Institute delivers integrated, comprehensive musculoskeletal and neurological care. It is built upon a foundation of pioneering research, academics, community service and a passion for excellence in patient care. The organization continues to be a leader in payor-reform initiatives, and it is at the forefront of systems-based quality programs, which drive value and improve the quality of patient care.

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, and the potential for DSUVIA to allow joint replacement patients to be more awake and alert in the PACU. 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.

SOURCE AcelRx Pharmaceuticals, Inc.