Physicians across Europe will now have access to DZUVEO®, a
novel sublingual approach to acute pain management in medically
supervised settings
HAYWARD,
Calif., Oct. 27, 2022 /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 that its commercial partner,
Laboratorie Aguettant ("Aguettant"), has launched DZUVEO®
(sufentanil sublingual tablet, 30 mcg), which is branded as DSUVIA®
in the U.S., across Europe.
Aguettant entered into a commercial collaboration with AcelRx in
2021 and has formally launched across key European countries,
except Spain, Portugal and Italy, for which commercialization is expected
to begin in the first half of 2023. Physicians across
Europe will now have access to
DZUVEO, a sublingual alternative to standard intravenous (IV)
opioid analgesics which have undesirable pharmacokinetic and
pharmacodynamic performance profiles characterized by high peak
plasma concentrations and the requirement for frequent
redosing. DSUVIA/DZUVEO was designed to provide rapid
analgesia via a non-invasive route and to eliminate high peak
plasma levels, provide longer duration of action, and avoid dosing
errors associated with IV administration. In addition, a
number of recently published U.S. studies demonstrate that a
sufentanil sublingual tablet, 30 mcg administered in various
medically supervised settings can lower overall perioperative
opioid use, as well as shorten recovery time, compared to IV
opioids.
"We are thrilled the Aguettant team has launched DZUVEO and has
now made this novel product available to healthcare professionals
outside the United States for the
first time," said Vince Angotti,
Chief Executive Officer of AcelRx. "We remain impressed with, and
are confident in the expertise of the Aguettant commercial team,
and believe that the recent DSUVIA growth seen over the last five
quarters here in the U.S. will support the Aguettant European
launch."
"Partnering with AcelRx and leveraging the knowledge they've
gained while commercializing DSUVIA in the U.S. has been extremely
useful while we prepared for our launch across Europe," said Eric Rougemond, CEO of
Aguettant. "We're excited to now have DZUVEO as part of our product
portfolio available to our existing customers. This is a
unique asset that we believe will have a profound positive impact
on the management of acute pain within hospitals and other
medically supervised settings," continued Mr. Rougemond.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
(branded as DZUVEO in Europe)
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, will market the drug
in Europe.
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.
There are certain regulatory aspects of DSUVIA and DZUVEO that
are different in the USA and
Europe. Please refer to the
Summary of Product Characteristics (SmPC) of DZUVEO in the European
countries concerned by the marketing of this specialty product.
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
This press release contains forward-looking statements based
upon AcelRx's current expectations. 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 "potential," "believe," "expect," "expected,"
"anticipate," "may," "will," "enable," "should," "seek,"
"approximately," "intends," "intended," "plans," "estimates,"
"benefits," or the negative of these words or other comparable
terminology. The discussion of financial trends, strategy, plans or
intentions may also include forward-looking statements, which are
predictions, projections and other statements about future events
that are based on current expectations and assumptions. 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, including:
(i) risks relating to AcelRx's product development activities and
ongoing commercial business operations; (ii) risks related to the
ability of AcelRx and its business partners to implement
development plans, launch plans, forecasts and other business
expectations; (iii) risks related to unexpected variations in
market growth and demand for AcelRx's commercial and developmental
products and technologies; (iv) risks related to AcelRx's liquidity
and our ability to maintain capital resources; (v) AcelRx's ability
to retaining its listing on the Nasdaq exchange; and (vi) risks
relating to our ability to obtain regulatory approvals for our
developmental product candidates. Although it is not possible to
predict or identify all such risks and uncertainties, they may
include, but are not limited to, those described under the caption
"Risk Factors" and elsewhere in AcelRx'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) and
any subsequent public filings. 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. To the degree
financial information is included in this press release, it is in
summary form only and must be considered in the context of the full
details provided in AcelRx's most recent annual, quarterly or
current report as filed or furnished with the SEC. AcelRx's SEC
reports are available at www.acelrx.com under the "Investors" tab.
Except to the extent required by law, AcelRx undertakes no
obligation to publicly release the result of any revisions to these
forward-looking statements to reflect new information, events or
circumstances after the date hereof, or to reflect the occurrence
of unanticipated events.
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SOURCE AcelRx Pharmaceuticals, Inc.