AcelRx Pharmaceuticals Announces Publication of Clinical Study Results Evaluating the Use of Sufentanil Sublingual Tablet for Painful Radiofrequency Microneedling Procedures

Study results show higher rates of successful procedure completion and higher patient and clinician satisfaction scores compared to topical local anesthesia alone

HAYWARD, Calif., March 31, 2022 /PRNewswire/ — AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on developing and commercializing innovative therapies for use in medically supervised settings, today announced the publication of a study evaluating the use of a sufentanil sublingual tablet (SST) 30 mcg for the management of pain from radiofrequency (“RF”) microneedling of the face or abdomen. The article titled “A new sublingual analgesic improves patients’ tolerance to radiofrequency microneedling of the face and body: a split face/abdomen study” was written by Dr. Maningas heel and published in the journal American journal of cosmetic surgery. Dr. Maningas is a nationally recognized cosmetic surgeon and is board certified by the American Board of Cosmetic Surgery, American Board of Facial Cosmetic Surgery, and American Osteopathic Board of Otolaryngology.

The study was a prospective, open-label, controlled study at two clinical sites comparing topical local anesthetic alone (control side) to topical local anesthetic plus SST 30 mcg administered 30 minutes before the start of RF microneedling to the face or neck. abdomen (SST – treated side). The study was a one-way face or abdomen crossover study, meaning one treatment was performed on one side of the face or abdomen and the other treatment on the opposite side, allowing patients to act as their own control. Outcome measures included the percentage of patients who successfully completed full treatment with predefined needle depth and RF energy parameters, Richmond Agitation-Sedation Scale (RASS) scores that objectively assess patient level of agitation or sedation, patient and clinician satisfaction scores, and vital parameters. adverse signs and events.

A total of 51 patients were evaluated at the two sites with 26 patients undergoing facial microneedling RF and 25 patients undergoing the procedure on the abdomen. The results of the study are as follows:

  • While only 45% of patients successfully completed the procedure on the control side, 96% of patients successfully completed the procedure on the SST-treated side (p

  • Patients were less agitated or agitated during the procedure on the SST-treated side (6% agitated or agitated) compared to the procedure on the control side (51% agitated or agitated), as measured using the RASS scoring system ; p

  • Patient-reported satisfaction with pain control improved significantly with the SST-treated lateral procedure compared to the control-treated lateral procedure (p

  • Clinician (provider) satisfaction with patient comfort level also improved significantly for the SST-treated side compared to the control side (p

  • Vital signs remained stable with the SST treatment compared to the control side and no patient required supplemental oxygen. Nausea and vomiting (5.9% each) and dizziness (2%) did not occur until both sides had completed the procedure and resolved symptoms with recovery room treatment.

Limitations of the study include the open-label design and, due to the half-life of SST, the study was performed as a one-way crossover from a topical local anesthetic only to an anesthetic topical local plus SST.

“RF microneedling is a minimally invasive cosmetic procedure, but in the most effective clinical settings it can be painful for many patients, making tolerance difficult,” Dr. Maningas said. “Before adopting DSUVIA® in our practice, we either had to reduce energy settings, which produced less effective results, or perform more invasive anesthesia measures. I now use DSUVIA as the standard of care for my RF microneedling procedures, which allows for more patient comfort, better cosmetic outcome and time savings in our busy practice.While the study showed a low rate of nausea and vomiting, we are now pre-treating with a oral antiemetic and rarely see these side effects.

“We have heard repeated feedback from physicians over the past few years that DSUVIA significantly improves patient comfort during painful cosmetic procedures, but this is the first prospective, controlled study demonstrating statistically significant superiority over a traditional pain regimen,” said Dr. Pamela Palmer, Medical Director and Co-Founder of AcelRx. “If patients are experiencing pain so severe that it may limit the effectiveness of a procedure, this should be recognized and corrected. DSUVIA provides an effective alternative approach to managing acute pain in these cosmetic procedural suites that can avoid reliance more complicated methods, such as the use of nerve blocks or intravenous sedation.”

AcelRx did not provide funding for the conduct of the study and no author was a consultant for AcelRx throughout the conduct of the study. Since accepting the manuscript for publication, Dr. Maningas has received funding for consulting work from AcelRx.

About DSUVIA (Sufentanil Sublingual Tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, is indicated for use in adults in certified medically supervised health care settings, such as hospitals, surgical centers and emergency departments, for the management of acute pain severe enough to require analgesia opioid, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia by a noninvasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a solid, single-strength dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic that was previously marketed only for IV and epidural anesthesia and analgesia. The pharmacokinetic profile of sufentanil when administered sublingually avoids the high plasma peaks and short duration of action observed with IV administration. The European Commission has approved the marketing of DZUVEO in Europe and it will be marketed by AcelRx’s European partner, Aguettant.

This press 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 environments. AcelRx’s proprietary non-invasive sublingual formulation technology provides sufentanil with consistent pharmacokinetic profiles. The company has an approved product in the United States, 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 in adult patients in certified healthcare facilities under medical supervision, and several product candidates. Product candidates include Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product under development in the United States as an innovative patient-controlled analgesia (PCA) system for the reduction of acute moderate to severe in medically supervised environments, and two of the pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the United States 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. Both DZUVEO and Zalviso are approved products in Europe.

For more information on AcelRx, please visit www.acelrx.com.

This press release is intended for investors only.

AcelRx logo. (PRNewsFoto/AcelRx Pharmaceuticals, Inc.) (PRNewsfoto/AcelRx Pharmaceuticals, Inc.)

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SOURCEAcelRx Pharmaceuticals, Inc.

Jacob L. Thornton