Minimal Side Effects and Short Recovery Time Reported for DSUVIA®-Treated Patients: Plastic Surgery Podium Presentation at The Aesthetic Meeting 2022

HAYWARD, Calif., April 25, 2022 /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 a summary of results from a podium presentation on DSUVIA® (sufentanil sublingual tablet (SST), 30 mcg) presented at the annual meeting of The Aesthetic Society®, "The Aesthetic Meeting 2022", held from April 20 -24 at the San Diego Convention Center.

The podium presentation was entitled "Improved Patient Experience and Opioid Minimalization in Outpatient Plastic Surgery Procedures Using a Sufentanil Sublingual Tablet" and was presented April 24^th by Hisham Seify, MD, PhD, FACS, a board-certified plastic surgeon, past-president of the Orange County Society of Plastic Surgeons, and Associate Clinical Professor at the David Geffen UCLA School of Medicine. Some of the data presented at the meeting were from an investigator-initiated trial supported by AcelRx. The data were collected from a total of 124 patients during both "awake" cosmetic procedures as well as patients undergoing more lengthy cosmetic procedures under general anesthesia. All 92 SST-treated patients received a single SST administered either 30 minutes prior to shorter-duration procedures, or 45 minutes prior to extubation for longer-duration procedures. The 32 "control" patients all received general anesthesia with standard intravenous (IV) opioids.

For patients undergoing general anesthesia, the control group required significantly more IV morphine milligram equivalents (MME) during recovery than SST-treated patients. The average dose of opioids administered in the post-anesthesia care unit (PACU) to control patients was more than five-fold higher than SST-treated patients, with controls receiving 3.60 ± 2.65 MME as contrasted with SST-treated patients that were administered an average of 0.64 ± 2.31 MME (p <.001).  In the awake surgery patients, no SST-treated patients required opioids or other analgesics in the PACU for pain. The mean recovery time was under an hour for the general anesthesia SST-treated patients and only 15 minutes for the awake cosmetic SST-treated patients.

Adverse events requiring medical intervention following general anesthesia were minimal in SST-treated patients with 1.6% requiring additional antiemetics in the PACU compared to 9.4% of control patients. In awake cosmetic patients, 3.2% of SST-treated patient required an antiemetic in the PACU for treatment of nausea.

"My extensive experience with operating on patients treated with DSUVIA, including the patients in this study, has reinforced my earlier observations that  DSUVIA is a unique sublingual alternative to IV opioids that can clearly enhance the standard of care in perioperative analgesia," states Dr. Seify. "Administering a sublingual opioid to surgical patients that is well-tolerated, avoids the traditional peaks and troughs of IV administration, and substantially reduces the use of postoperative opioids, thereby facilitating a timely discharge, represents an exciting progression in the management of perioperative pain in the surgical setting," 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. DZUVEO has been approved by the European Medicines Agency and AcelRx's European commercialization partner, Aguettant, will market the drug in Europe.

This release is intended for investors only.  For more information, including important safety information and a 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, including the following:  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; two pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the U.S. from Aguettant; Niyad™ (nafamostat mesylate), a regional anticoagulant for the extracorporeal circuit; and, LTX-608 for the potential treatment of COVID-19, disseminated intravascular coagulation, acute respiratory distress syndrome and acute pancreatitis. DZUVEO and Zalviso are both approved products in Europe.

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

This release is intended for investors only.

 

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SOURCE AcelRx Pharmaceuticals, Inc.

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