Study Results Announced During Award-Winning Presentation on the Effect of Sufentanil Sublingual Tablet on Outpatient Plastic Surgery at the Annual Miami Cosmetic Surgery Event
HAYWARD, Calif., Aug. 30, 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 the results of a study evaluating sufentanil sublingual tablet 30 mcg (SST) for outpatient plastic surgery that was presented during the Miami Cosmetic Surgery (MCS) conference on Friday, August 27th at the Miami Beach Convention Center in Miami Beach, Florida.
The presentation by Azza Halim, MD and Hisham Seify, MD, PhD, FACS shared data on the administration of SST and its effect on reducing post-operative recovery time and opioid use in the outpatient plastic surgery setting in patients undergoing "awake" procedures not under general anesthesia. The authors were presented with a MCS 2021 Maverick Program Award in which the recipients' "progressive, innovative ideas have been recognized for the lasting impact they will have on medical aesthetics."
The presentation detailed the protocol for dosing SST 30 minutes prior to starting awake plastic surgery procedures. A total of 25 cases were analyzed, with an average patient age of 46.1 ± 2.4 years and 92% were female. The cases were mainly liposuction (68%), followed by facelifts (12%), blepharoplasties (8%) and 3 other cases with an average duration of 1 hr 24 min ± 10 min. Following the preoperative SST dose and local anesthetic infiltration, no other analgesics were required throughout the intraoperative and recovery period with recovery time averaging 15 ± 5 min. There were 2 cases of nausea, only one of which required treatment with ondansetron 4 mg oral disintegrating tablet, and no cases of vomiting or any other adverse events. The presenters emphasized the reduction in opioid use and recovery time that the addition of SST has had on their practice.
Dr. Halim is a board-certified anesthesiologist who specializes in cosmetic surgeries. Dr. Seify is a board-certified plastic surgeon and the past-president of the Orange County Society of Plastic Surgeons. "Dosing a single preoperative SST allowed us to avoid any additional analgesic administration during both the intraoperative and recovery periods, which resulted in these patients being ready for discharge almost immediately following these fairly lengthy procedures," states Dr. Seify. "The low rate of side effects also avoided prolonged delays during recovery," states. Dr. Seify.
Dr. Seify is a paid consultant for AcelRx but was not compensated for this study. Dr. Halim is not a paid consultant for AcelRx. Limitations of this study are that it was a single-arm, open-label case series.
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.
SOURCE AcelRx Pharmaceuticals, Inc.
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