HAYWARD, Calif.

,

Jan. 12, 2022

/PRNewswire/ — AcelRx Pharmaceuticals, Inc. (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 an editorial regarding the use of sufentanil sublingual tablet (SST; DSUVIA®) in total joint replacement surgery by Dr.

Scott Sigman

in the

Journal of Orthopaedic Experience and Innovation.

Dr. Sigman is a board-certified orthopedic surgeon at Orthopedic Surgical Associates of

Lowell

, the former Chief of Orthopedics at Lowell General Hospital in

Lowell Massachusetts

, and an internationally recognized leader in opioid-sparing orthopedic surgery.

Dr. Sigman’s editorial, entitled “Opioid Stewardship: Is There a “Better” Opioid?,” reflects his expert opinion on the recently published article in the same journal entitled “Reduced opioid use and hospital stay in patients undergoing total knee or total hip arthroplasty when treated with sublingual sufentanil compared with standard analgesic care” which was co-authored by Dr.

Lawrence Wiesner

and Dr.

Christian Tvetenstrand

from the United Health Services Orthopedic Center in

Vestal, New York

and Southern Tier Surgical Clinic in

Johnson City

, New York.  The study prospectively evaluated patients who were administered a single SST 30 mcg in the perioperative period and compared their length of stay and overall opioid use to matched historical control patients receiving standard IV opioids.

In the editorial, Dr. Sigman emphasizes the importance of minimizing opioid exposure to the patient as part of good Opioid Stewardship practices, and that physicians using Enhanced Recovery After Surgery (ERAS) protocols must consider whether there is an opportunity to further reduce perioperative opioid exposure by the selection of the opioid analgesic they utilize. Dr. Sigman highlights the results from the Dr. Wiesner study, which demonstrated an approximately 30% reduction in both overall opioid use and hospital length of stay in the SST-treated patients compared to the IV opioid group, as well as a reduction in the SST group of the number of patients requiring discharge to a skilled nursing facility instead of being discharged to home.

As highlighted in the editorial, Dr. Sigman believes the results of this study identify SST as a viable option for the advancement of the ideals of Opioid Stewardship with the potential to reduce opioid utilization, which could potentially reduce opioid-related adverse events, length of stay, and possibly decrease the risk of physical dependence and addiction in the postoperative period. While the study was not double-blinded or placebo-controlled and the control group was a historical cohort, Dr. Sigman states, “The fact that the patient selection was not stringent, and that multiple types of surgeries and anesthetic techniques were included, may in fact allow a better sense of the utility of SST in a real-world clinical setting compared to a highly controlled trial.”

“We expect Dr Sigman’s commentary on the importance of SST in reducing the exposure of patients to opioids in the perioperative setting to resonate with his surgical colleagues given his international profile as an opioid-sparing surgeon” said Dr. Pamela Palmer, AcelRx Chief Medical Officer and co-founder. “His advocacy of SST as a viable option to advance the ideals of Opioid Stewardship is a notable declaration of the potential importance of SST in the perioperative setting,” continued Dr. Palmer.

Dr. Sigman is a paid consultant for AcelRx but was not compensated for this editorial. Dr. Wiesner is not a paid consultant for AcelRx. Dr. Tvetenstrand is a paid consultant for AcelRx but was not compensated for the study that is the subject of the editorial. AcelRx did not provide funding for the conduct of the study that is the subject of the editorial but did fund medical writing support.

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 it will be commercialized by AcelRx’s European partner, Aguettant.

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 several product candidates.  The product candidates include Zalviso

^®

(sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S. being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings, and two pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the U.S. from Aguettant. DZUVEO and Zalviso are both approved products in

Europe

.

For additional information about AcelRx, please visit

www.acelrx.com

.

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SOURCE AcelRx Pharmaceuticals, Inc.