HAYWARD, Calif.

,

June 1, 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 important findings from a podium presentation on DSUVIA (sufentanil sublingual tablet 30 mcg) during the

Best Papers of the Regional Societies

session at the California Society of Plastic Surgeons 71

^st

Annual Meeting in

Monterey CA.

The presentation entitled “The Use of Sublingual Sufentanil for Peri-operative Pain Management in an Outpatient and Clinic Setting” was presented on

May 31

, 2021 by

Hisham Seify

, MD, PhD, FACS and reported on data collected from a total of 76 patients during both short and long-duration general anesthesia plastic surgery cases as well as “awake” cosmetic procedures performed at the Newport Plastic and Reconstructive Surgery’s center. Procedures were performed utilizing a single DSUVIA tablet in combination with general anesthesia. Patients undergoing short (< 1 hour) procedures required no opioids in the postanesthesia care unit (PACU) and had an average recovery time of 33 minutes with no adverse events reported. Following long-duration procedures, which often included multiple cosmetic procedures combined (averaging approximately 3 hours), 89% of the patients were opioid-free in the PACU, recovery time averaged 1 hour and the only adverse event was one patient that had nausea. Dr. Seify also presented his protocol for using DSUVIA during “awake” surgery cases and reported that to date they had seen no adverse events or vital sign instability in these patients. The data presented at the meeting are from an investigator-initiated trial supported by AcelRx. Dr. Seify is a paid consultant for AcelRx.

“The results from these 76 patients demonstrated that the use of DSUVIA allowed for enduring pain control into the postoperative period regardless of whether the surgical procedure was short or extensive, with little need for rescue opioids during recovery,” states Dr. Seify. “The almost complete lack of adverse events experienced by these patients, including no sedating effects of DSUVIA, allowed us to discharge them in an hour or less, even when they underwent a 3-hour procedure,” continues Dr. Seify.

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

.

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SOURCE AcelRx Pharmaceuticals, Inc.