REDWOOD CITY, Calif.,
Oct. 12, 2017
/PRNewswire/-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX)
(AcelRx), a specialty pharmaceutical company, today announced that
it received a Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA) regarding its New Drug Application (NDA)
for DSUVIA™ (sufentanil sublingual tablet), 30
mcg.
The CRL states that the FDA determined it cannot approve the NDA
in its present form and provides recommendations needed for
resubmission. The two primary recommendations within the CRL are:
first, while the safety database was suitable in number of
patients, the collection of additional data was requested on at
least 50 patients to assess the safety of DSUVIA dosed at the
maximum amount described in the proposed labelling; second, to
ensure proper administration of the tablet with the single-dose
applicator, the FDA recommended certain changes to the Directions
for Use to address use-related errors, including dropped tablets,
to be validated through a human factors study.
"We believe the recommendations stated in the CRL are manageable
and plan to fully cooperate with the FDA. We remain focused
on the NDA resubmission and our mission to provide physicians and
patients with precise and efficient non-invasive pain management
options for moderate-to-severe acute pain within medically
supervised settings," said Vincent J.
Angotti, chief executive officer, AcelRx.
AcelRx will request a meeting with the FDA to discuss the topics
covered in the CRL, and confirm plans to move towards resubmission
of the DSUVIA NDA. AcelRx ended the third quarter with an estimated
$67.9 million in cash and we will
provide further financial updates on our third quarter earnings
call.
Conference Call
AcelRx's management will host a
conference call on Thursday, October 12,
2017, at 9:00AM ET to discuss
the Complete Response Letter. The dial-in number for the conference
call is 1-866-361-2335 for domestic participants and 1-412-902-4204
for international participants. A live webcast of the conference
call can also be accessed through the "Investors" tab on the AcelRx
Pharmaceuticals website, and a replay will be available online
after the call.
About DSUVIA™ (sufentanil sublingual
tablet), 30 mcg
DSUVIA™ (sufentanil
sublingual tablet, SST, 30 microgram), known as ARX-04 outside
the United States, is designed to
reduce moderate-to-severe acute pain and dosing errors associated
with IV administration via its non-invasive single-dose applicator
(SDA) in medically supervised settings. Sufentanil is an opioid
analgesic currently marketed for intravenous (IV) and epidural
anesthesia and analgesia. However, its use has been limited due to
its short duration of action when delivered intravenously.
The sufentanil pharmacokinetic profile when
delivered sublingually potentially avoids the high peak plasma
levels and short duration of action observed with IV
administration. In the EU, the European Medicines
Agency (EMA) has notified the company that the ARX-04
Marketing Authorization Application (MAA) is under scientific
review.
About AcelRx Pharmaceuticals, Inc.
AcelRx
Pharmaceuticals, Inc. is a specialty pharmaceutical company
focused on the development and commercialization of innovative
therapies for the treatment of moderate-to-severe acute pain.
AcelRx's proprietary, non-invasive sublingual formulation
technology delivers sufentanil with consistent pharmacokinetic
profiles.
The company is simultaneously developing
ZALVISO® (sufentanil sublingual tablet
system, SST system, 15 microgram) as an innovatively designed
patient-controlled analgesia (PCA) system for reduction of
moderate-to-severe pain in medically supervised settings. The
company recently completed a Phase 3 clinical trial, IAP312, which
included input from the FDA on the study protocol. This
study was designed to evaluate the effectiveness of changes made to
the functionality and usability of the ZALVISO device, to evaluate
the incidence of inadvertent dosing, and to take into account
comments from the FDA on the study protocol. AcelRx
intends to resubmit the NDA for ZALVISO to the FDA by the
end of the year. AcelRx has successfully received EU Marketing
Approval for ZALVISO® in the EU. Grunenthal
Group holds the rights for ZALVISO®
in Europe, where a commercialization across multiple countries
is underway. In June 2017,
ZALVISO® was selected for
a Red Dot Award in the category of Product Design – Life Sciences
and Medicine.
For additional information about AcelRx's clinical programs,
please visit www.acelrx.com.
Forward-Looking Statements
This press release
contains forward-looking statements, including, but not limited to,
statements related to the process and timing of anticipated future
development of AcelRx's product candidates,
DSUVIA™ (sufentanil sublingual tablet,
30 mcg), known as ARX-04 outside the United States, and
ZALVISO® (sufentanil sublingual tablet
system), including U.S. Food and Drug Administration,
or FDA, review of the New Drug Application, or NDA, for
DSUVIA; and evaluation of the CRL and AcelRx's plans for
resubmission of the NDA for DSUVIA with the FDA. These
forward-looking statements are based on AcelRx
Pharmaceuticals' current expectations and inherently involve
significant risks and uncertainties. AcelRx
Pharmaceuticals' actual results and timing of events could
differ materially from those anticipated in such forward-looking
statements, and as a result of these risks and uncertainties, which
include, without limitation, risks related to AcelRx
Pharmaceuticals' DSUVIA and ARX-04 development programs,
including the EMA review of the ARX-04 MAA, and the possibility
that EMA may dispute or interpret differently clinical results
obtained from the ARX-04 Phase 2 and 3 studies; the possibility
that the FDA may dispute or interpret differently the
results of the ZALVISO development program, including the results
from the IAP312 clinical trial; the resubmission of the ZALVISO NDA
to the FDA; any delays or inability to obtain and maintain
regulatory approval of its product candidates, including DSUVIA
in the United States, ARX-04
in Europe and ZALVISO in the United States; the uncertain clinical
development process, including adverse events; the success, cost
and timing of all development activities and clinical trials; the
accuracy of AcelRx's estimates regarding expenses, capital
requirements and the need for financing; and other risks detailed
in the "Risk Factors" and elsewhere in AcelRx's U.S.
Securities and Exchange Commission filings and reports,
including its Quarterly Report on Form 10-Q filed with
the SEC on August 2, 2017. 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.
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SOURCE AcelRx Pharmaceuticals, Inc.