Study is the first to report on the use of
DSUVIA® in the rapidly growing field of rhinology where
otolaryngologists are performing painful nasal and sinus procedures
in the office which were historically conducted only in ambulatory
surgery centers or hospitals
HAYWARD,
Calif., March 1, 2023 /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 publication of a report
arising from a series of rhinology procedures successfully
performed using sufentanil sublingual tablet 30 mcg (SST; DSUVIA)
in Otolaryngology Case Reports. The study was lead-authored
by otolaryngologist Dr. Ashley
Sikand and entitled "Evaluation of Sufentanil Sublingual
Tablet 30 mcg for Perioperative Pain Management of In-Office
Rhinology Procedures."
The single-center, prospective, case series study was conducted
at the Ear, Nose and Throat Consultants of Nevada in Las Vegas,
NV and evaluated a total of 77 patients with respect to
quality of perioperative pain management in patients undergoing a
combination of rhinology procedures. Patients ranged in age from 22
– 73 years of age with the majority classified as American Society
of Anesthesiologists (ASA) Physical Status 1 or 2 (healthy or mild
systemic disease), and only 8% classified as ASA 3 (severe systemic
disease). Most patients underwent a combination of procedures
including balloon sinuplasty, submucosal resection of inferior
turbinates and septoplasty. Patients were premedicated with oral
lorazepam 1-2 mg to decrease anxiety followed by oral ondansetron 4
mg as a prophylactic antiemetic. SST 30 mcg was then administered
sublingually. Throughout this preoperative period, topical and
infiltrated local anesthetic was applied to the nasal cavity. The
procedures ranged in duration from 30 to 90 minutes. Patients
were comfortable throughout the procedure and no patient required
additional dosing of analgesics. The authors reported that the
prolonged analgesic tail produced by the 13-hour half-life of SST
allowed patients to utilize fewer oral opioids once they were
home.
Vital signs and oxygen saturation were monitored during the
procedures and there was no incidence of vital sign instability and
no supplemental oxygen was required, although oxygen and reversal
agents were available if needed. One patient experienced nausea and
two patients experienced vomiting after the procedures were
completed.
"We are now routinely performing complex rhinology procedures in
our office procedural suite and, while local anesthetics are the
mainstay of analgesia for these procedures, certain patients need
additional opioid-level analgesia for acute pain management,"
stated Dr. Sikand. "Administering DSUVIA sublingually in
combination with anesthetizing the nasal cavity allows a rapid and
profound analgesia that extends throughout the duration of the
procedure. Patients are alert enough to respond to questions but
are very comfortable throughout these procedures as well as during
the transition home, improving the overall patient experience.
DSUVIA has increased both physician and staff satisfaction as well
as patient satisfaction with the level of analgesia during these
procedures."
"Office-based rhinology is a rapidly growing field that allows
patients and physicians to avoid the more costly and inconvenient
ambulatory surgery centers and hospitals. The only limitation to
the office-based approach is patient tolerability of these painful
procedures," stated Dr. Pamela
Palmer, Founder and Chief Medical Officer of AcelRx. "Dr.
Sikand is a leader in this field, having developed and taught these
surgical protocols for the past decade. We are excited that DSUVIA
can help patients manage acute pain during rhinology surgery in an
office-based setting with a well-tolerated side-effect
profile."
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, branded 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/DZUVEO was designed to provide rapid
analgesia via a non-invasive route and to eliminate dosing errors
associated with intravenous (IV) administration. DSUVIA/DZUVEO 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, markets the drug in Europe.
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; two pre-filled, ready-to-use syringes of ephedrine and
phenylephrine licensed for the U.S. from Aguettant;
Niyad™, 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 is an approved product
in Europe.
This release is intended for investors only. For additional
information about AcelRx, please visit www.acelrx.com.
Forward-looking statements
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forward-looking statements based upon AcelRx's current
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