HAYWARD, Calif., May 19, 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 reported that the U.S. Food and Drug
Administration (FDA) has recently modified the DSUVIA Risk
Evaluation and Mitigation Strategies (REMS) requirements with
respect to healthcare setting audits. The goal of the DSUVIA REMS
program is to mitigate the risk of respiratory depression resulting
from accidental exposure by ensuring that DSUVIA is dispensed only
to patients in certified medically supervised healthcare
settings.
On April 21, 2022, the FDA revised
the DSUVIA REMS program to eliminate the 6-month healthcare setting
audit requirement and reduce annual healthcare setting audits to a
total of up to 400 sites that have received a shipment of DSUVIA in
the past 6 months. Previously, the DSUVIA REMS required
AcelRx to audit all healthcare settings within six months of
an initial DSUVIA order, and to then continue to audit all such
sites annually thereafter (for sites continuing to order DSUVIA
within a six-month period), with no limit to the number of sites
audited.
"We continue to work closely with the FDA on the DSUVIA REMS
program and have established a track record of compliance and
safety with DSUVIA, including lack of accidental exposure," said
Pamela Palmer, MD, PhD, Co-Founder
and Chief Medical Officer of AcelRx. "We believe that it is this
history of stewardship and responsibility, which is included in our
latest three-year assessment REMS report as submitted to the FDA,
that has resulted in the lowering of both the number and frequency
of required site audits," continued Dr. Palmer.
About the U.S. Food and Drug Administration (FDA) Risk
Evaluation and Mitigation Strategies (REMS) Requirements
In general, the FDA's Risk Evaluation and Mitigation Strategies
(REMS) programs include a risk mitigation goal and are comprised of
information communicated to and/or required activities to be
undertaken by one or more participants (e.g., health care
providers, pharmaceutical wholesalers and distributors,
pharmacists, patients) who prescribe, dispense or take the
medication. Together, the goal, communications and/or
activities make up the safety and risk mitigation strategy.
Each prong of a REMS program is designed to help one or more of
the key participants in that REMS program to address a specific
risk or safety concern. The most common role(s) of each of these
key participants in a REMS are further described elsewhere.
The specific requirements and risk messages of each REMS program is
tailored to the specific medication subject to REMS, the nature of
its risks, and the likely setting in which the drug will be, or is
being, used.
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. 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.
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 and Zalviso are both approved products 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,
including, but not limited to, statements related to the expected
effectiveness and scope of the Company's past and future compliance
with its FDA obligations including with respect to the DSUVIA REMS
program. 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 "believe,"
"expect," "expected," "continue," establish," "may," "will," or the
negative of these words or other comparable terminology. The
discussion of strategy, compliance programs, and any related 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) the risk that the Company may be found to be
not in compliance with its regulatory obligations including those
arising under the DSUVIA REMS program; (ii) risks related to the
ability of AcelRx to implement its development and
commercialization plans in a compliant manner, or meet its
forecasts and other business expectations; and (iii) risks that the
Company may not be able to effectively commercialize DSUVIA.
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-provides-update-on-reduced-fda-rems-requirements-related-to-dsuvia-301550921.html
SOURCE AcelRx Pharmaceuticals, Inc.