HAYWARD, Calif., June 17, 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 it has reached agreement with
the Food and Drug Administration (FDA) with regards to finalizing
corrective actions AcelRx has taken or plans to take in response to
the previously announced FDA warning letter, dated February 11, 2021, regarding certain DSUVIA
promotional materials.
The FDA has agreed with AcelRx's proposed plan to update
certain promotional materials, including providing a letter to
healthcare professionals (DHCP letter) explaining the corrections
to the discontinued promotional materials. AcelRx will also
include this DHCP letter on the DSUVIA.com website for a period of
eight months. All promotional materials currently in use by
AcelRx's commercial team have been updated to address the FDA's
concerns. AcelRx expects to receive a close-out letter from
the FDA after the DHCP letters have been sent to the identified
healthcare professionals and the letter has been posted on the
website for eight months.
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 the FDA warning letter, including
the expected receipt of a close-out letter from the FDA. 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.