REDWOOD CITY, Calif.,
June 27, 2018 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the
Company), a specialty pharmaceutical company focused on innovative
therapies for use in medically supervised settings, today announced
that the European Commission (EC) has approved DZUVEO (under
development in the U.S. as DSUVIA™) for the management of acute
moderate to severe pain in adults in medically monitored
settings.
"The EC approval is an important milestone for AcelRx, and an
exciting new opportunity for healthcare providers for managing
acute moderate to severe pain in medically monitored settings. The
current standard of care in these settings is primarily intravenous
opioids," said Vince Angotti, Chief
Executive Officer of AcelRx. "DZUVEO is a novel, non-invasive,
sublingual tablet that we expect will challenge the current
standard of care and provide a new option to healthcare
practitioners that does not require the time, expense and effort to
start an intravenous line."
DZUVEO represents the second EC approval for an AcelRx developed
product, with the first being ZALVISO, which is currently being
marketed in Europe by
Grünenthal.
AcelRx previously announced the acceptance of the resubmitted
New Drug Application for DSUVIA (approved in Europe as DZUVEO) by the U.S. Food and Drug
Administration, for which the FDA has assigned a PDUFA
(Prescription Drug User Fee Act) date of November 3, 2018.
About DZUVEO (tradename of DSUVIA in the U.S.)
DZUVEO
(sufentanil sublingual tablet, 30 microgram), under development as
DSUVIA in the U.S., is designed to reduce acute moderate-to-severe
pain in medically monitored settings and address dosing errors
associated with intravenous (IV) administration via its
non-invasive single-dose applicator (SDA). Sufentanil is an opioid
analgesic currently 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 while still providing
rapid pain relief. The safety and clinical utility of DZUVEO has
been established in patients following multiple types of surgery,
as well as in patients presenting to the emergency room with
moderate to severe pain due to trauma, injury or illness. In
the U.S., the U.S. Food and Drug Administration assigned the
Company a Prescription Drug User Fee Act (PDUFA) date of
November 3, 2018 for a decision on
its resubmitted DSUVIA NDA (New Drug Application).
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 two
product candidates in the United
States, including DSUVIA™ (sufentanil sublingual
tablet, 30 mcg), known as DZUVEO™ outside the United States, with a proposed indication
for the treatment of moderate to severe acute pain in medically
supervised (or monitored) settings, and Zalviso®
(sufentanil sublingual tablet system, SST system, 15 mcg) being
developed as a non-invasive patient-controlled analgesia (PCA)
system for treatment of moderate to severe acute pain in medically
supervised settings. The Company has received EC approval for
Zalviso and DZUVEO for marketing in the Europe.
For additional information about AcelRx's clinical programs,
please visit www.acelrx.com.
Forward-Looking Statements
This press release
contains forward-looking statements, including, without limitation,
the statement related to the size and significance of a potential
market for DZUVEO in Europe and
the potential that DZUVEO will challenge the standard of care in
the management of acute moderate to severe pain. This and similar
forward-looking statements are based on AcelRx's current
expectations and involve significant risks and uncertainties.
AcelRx's actual results and timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, including
without limitation, any delays or the inability to obtain and
maintain market acceptancy of DZUVEO in Europe, or any other risks described in the
"Risk Factors" and elsewhere in AcelRx's U.S. Securities and
Exchange Commission (SEC) filings and reports, including its
Quarterly Report on Form 10-Q filed with the SEC on May 10, 2018. AcelRx undertakes no duty or
obligation to update any forward-looking statements contained in
this release as a result of new information, future events or
changes in its expectations, except as required by law.
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SOURCE AcelRx Pharmaceuticals, Inc.