REDWOOD CITY, Calif.,
Nov. 14, 2018 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for the use in medically supervised settings,
today announced an upcoming presentation at the 17th Annual Pain
Medicine Meeting of the American Society of Regional Anesthesia and
Pain Medicine (ASRA). The presentation is part of the Emerging
Technology Moderated Poster session. ASRA's Annual Pain Medicine
Meeting will take place November 15-17,
2018 in San Antonio,
TX.
This presentation analyzes postoperative analgesic drug dosing
in a multi-center, randomized open-label, parallel-group study
comparing IV morphine sulfate to sufentanil sublingual tablets
(SST). Over the first five hours, patient dosing in each treatment
arm suggests that a single 15 mcg or 30 mcg tablet has the
equivalent analgesic effect to approximately 2.5 mg or 5 mg of IV
morphine, respectively.
Details on the
presentation are as follows:
|
Title:
|
IV Morphine
Equivalence of the Sufentanil Sublingual Tablet Based on Dosing
Analyses from a Phase 3 Active Comparator Trial (Moderated Poster
#6012)
|
Authors:
|
Timothy Melson, MD of
Helen Keller Hospital; Harold Minkowitz, MD of the Memorial Hermann
Memorial City Medical Center in Houston, TX; Jacob Hutchins, MD of
University of Minnesota; and Pamela P. Palmer, MD, PhD and Karen
DiDonato, MSN, RN of AcelRx Pharmaceuticals.
|
Date/Time:
|
Friday, November 16,
2018; 10:30am-12:15pm CT
|
Location:
|
Session MP-06a,
Cibolo 4, JW Marriott San Antonio Hill Country
|
The American Society of Regional Anesthesia and Pain Medicine
(ASRA) is one of the largest subspecialty medical societies in
anesthesiology with nearly 5,000 members in 66 countries on 6
continents. For more information, please visit www.asra.com.
About DSUVIA™ (sufentanil sublingual tablet, 30
mcg)
DSUVIA™, known as DZUVEO™ outside the
United States, approved by the FDA
in November 2018, is indicated for
use in adults in a certified medically supervised healthcare
setting, 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
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
currently marketed for intravenous (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 Medicines Agency (EMA) approved DZUVEO for marketing in
Europe in June 2018. For more information, please visit
www.DSUVIA.com.
LIMITATIONS OF USE
Not for home use or for use in
children. Discontinue treatment with DSUVIA before patients leave
the certified medically supervised healthcare setting. Not for use
for more than 72 hours. The use of DSUVIA beyond 72 hours has not
been studied. Only to be administered by a healthcare provider.
Because of the risks of addiction, abuse, and misuse with
opioids, even at recommended doses, reserve DSUVIA for use in
patients for whom alternative treatment options [e.g., non-opioid
analgesics or opioid combination products]: have not been
tolerated, or are not expected to be tolerated, have not provided
adequate analgesia, or are not expected to provide adequate
analgesia.
The Full Prescribing Information for DSUVIA contains the
following Boxed Warning:
WARNING: ACCIDENTAL EXPOSURE AND DSUVIA REMS PROGRAM:
LIFE-THREATENING RESPIRATORY DEPRESSION; ADDICTION, ABUSE AND
MISUSE; CYTOCHROME P450 3A4 INTERACTION; AND RISKS FROM CONCOMITANT
USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Accidental Exposure and DSUVIA REMS
Program:
Accidental exposure to or ingestion of DSUVIA,
especially in children, can result in respiratory depression and
death. Because of the potential for life-threatening respiratory
depression due to accidental exposure, DSUVIA is available only
through a restricted program called the DSUVIA REMS Program. DSUVIA
must only be dispensed to patients in a certified medically
supervised healthcare setting. Discontinue use of DSUVIA prior to
discharge or transfer from the certified medically supervised
setting.
Life-Threatening Respiratory
Depression:
Serious, life-threatening,
or fatal respiratory depression may occur with the use of DSUVIA.
Monitor for respiratory depression, especially during initiation of
DSUVIA.
Addiction, Abuse, and Misuse:
DSUVIA exposes
patients and other users to the risks of opioid addiction, abuse,
and misuse, which can lead to overdose and death. Assess patient's
risk before prescribing DSUVIA, and monitor all patients regularly
for the development of these behaviors or conditions.
Cytochrome P450 3A4 Interaction:
The
concomitant use of DSUVIA with cytochrome P450 3A4 inhibitors may
result in an increase in sufentanil plasma concentrations, which
could increase or prolong adverse drug reactions and may cause
potentially fatal respiratory depression. In addition,
discontinuation of a concomitantly used cytochrome P450 3A4 inducer
may result in an increase in sufentanil plasma concentration.
Monitor patients receiving DSUVIA and any CYP3A4 inhibitor or
inducer.
Risks From Concomitant Use With Benzodiazepines or Other CNS
Depressants:
Concomitant use of opioids with benzodiazepines
or other central nervous system (CNS) depressants, including
alcohol, may result in profound sedation, respiratory depression,
coma, and death. Reserve concomitant prescribing for use in
patients for whom alternative treatment options are inadequate;
limit dosages and durations to the minimum required; and follow
patients for signs and symptoms of respiratory depression and
sedation.
IMPORTANT SAFETY INFORMATION
DSUVIA is contraindicated
in patients with significant respiratory depression; acute or
severe bronchial asthma in an unmonitored setting or in the absence
of resuscitative equipment; known or suspected gastrointestinal
obstruction, including paralytic ileus; and known hypersensitivity
to sufentanil or components of DSUVIA.
DSUVIA contains sufentanil, a Schedule II controlled substance.
As an opioid, DSUVIA exposes users to the risks of addiction,
abuse, and misuse. Potential serious adverse events caused by
opioids include addiction, abuse, and misuse, life-threatening
respiratory depression, neonatal withdrawal syndrome, risks of
concomitant use or discontinuation of cytochrome P450 3A4
inhibitors and inducers, risks from concomitant use with
benzodiazepines or other CNS depressants, risk of life threatening
respiratory depression in patients with chronic pulmonary disease
or in elderly, cachectic, or debilitated patients, adrenal
insufficiency, severe hypotension, risks of use in patients with
increased intracranial pressure or impaired consciousness,
gastrointestinal disorders and seizure disorders. DSUVIA should be
used with caution in patients with severe liver or kidney
impairment.
For Important Safety Information including full prescribing
information, visit: www.DSUVIA.com.
Clinical and Rehabilitative Medicine Research Program
(CRMRP)
DSUVIA was funded in part by the Clinical and Rehabilitative
Medicine Research Program (CRMRP) of the U.S. Army Medical
Research and Materiel Command (USAMRMC) under contract No.
W81XWH-15-C-0046. The CRMRP was established in 2008 to foster
research and technology advances for regeneration, restoration, and
rehabilitation of traumatic injuries. In accordance with USAMRMC
guidelines, in the conduct of clinical research, AcelRx has adhered
to the policies regarding the protection of human subjects as
prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1,
Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1,
Part 50 (Protection of Human Subjects).
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) 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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-to-present-at-the-17th-annual-asra-pain-medicine-meeting-300750664.html
SOURCE AcelRx Pharmaceuticals, Inc.