HAYWARD, Calif., May 20, 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 an investigator-initiated
study to be conducted at Tampa General Hospital to evaluate the use
of DSUVIA for patients with sickle cell disease presenting to the
emergency department (ED) with painful vaso-occlusive crisis
(VOC).
The study will enroll 100 patients presenting to the emergency
department with VOC who are administered DSUVIA to manage the
patients' moderate-to-severe acute pain until an IV line can be
accessed. The IV line is important for hydration, high-dose IV
opioid administration as these patients are often opioid-tolerant,
as well as administration of other parenteral medications.
Endpoints will include the time from arrival in the ED to first
analgesic medication, ED length of stay, hospital admission rates,
patient and clinician satisfaction, and adverse events. Patients
administered DSUVIA will be compared to a historical ED control
group who received routine pain management for VOC, including
waiting until IV access is established before opioids are
administered.
The study's principal investigator is Jason Wilson, MD, MA, CPHQ, FACEP. Dr. Wilson is
an attending emergency medicine physician serving as Director of
the ED Clinical Decision Unit, Tampa General Hospital at
TeamHealth. In this capacity, he is responsible for developing and
implementing protocols and patient pathways that improve throughput
metrics and quality of care for patients. Dr. Wilson also serves as
an Associate Professor and core faculty for the University of South Florida College of Medicine,
Division of Emergency Medicine, and as Research Director of the
University of South Florida, Emergency
Medicine Residency Program, Tampa General Hospital.
"I see patients with sickle cell disease presenting with VOC
every day in the ED. I am working to establish trust with these
patients who have often experienced a lifetime of under-controlled
pain and frequent visits and readmissions to the hospital," states
Dr. Wilson. "Often these patients have already tried oral
medications at home and present to us with severe acute pain.
Unfortunately, IV access can be difficult to obtain in these
patients and often requires ultrasound-guided IV placement, which
means it may take hours before patients receive strong opioid
analgesics, which are the mainstay of treatment for their severe
pain. Oral pain medication does not serve as a sufficient bridge
and another option is needed. Our early experience with DSUVIA
indicates that this rapid-onset sublingual option may be an
effective analgesic bridge that manages pain while practitioners
establish IV access in these opioid-tolerant patients, allowing
early and proactive pain management in patients with VOC which
could build trust in the patient encounter and avoid admissions,"
continued Dr. Wilson.
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 the Company is currently in
discussions with potential European marketing partners.
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
one product candidate, Zalviso® (sufentanil sublingual
tablet system, SST system, 15 mcg), an investigational product in
the U.S., is 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.
Forward-Looking Statements
This press
release contains forward-looking statements, including, but not
limited to, statements related to expected commencement of an
investigator-initiated study, the scope of the study, expected
analysis of clinical data, the potential for DSUVIA to be an
effective analgesic bridge for patients with sickle cell
disease presenting with VOC and the potential for proactive pain
management in patients with VOC to build trust in the patient
encounter and avoid admissions. These and any other
forward-looking statements are made pursuant to the
safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. These statements may be identified by the use
of forward-looking terminology such as "believes," "expects,"
"anticipates," "may," "will," "should," "seeks," "approximately,"
"intends," "plans," "estimates," or the negative of these words or
other comparable terminology. The discussion of strategy, plans or
intentions may also include forward-looking statements. These
forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
projected, anticipated or implied by such statements. In addition,
such risks and uncertainties may include, but are not limited to,
those described in the Company's annual, quarterly and current
reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or
furnished with the Securities and Exchange Commission (SEC). You
are cautioned not to place undue reliance on any such
forward-looking statements, which speak only as of the date such
statements were first made. The Company's SEC reports are available
at www.acelrx.com under the "Investors" tab. Except to the extent
required by law, the Company undertakes no obligation to publicly
release the result of any revisions to these forward-looking
statements to reflect events or circumstances after the date
hereof, or to reflect the occurrence of unanticipated
events.
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SOURCE AcelRx Pharmaceuticals, Inc.