REDWOOD CITY, Calif.,
Sept. 27, 2016 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
moderate-to-severe acute pain, announced today the initiation of
the Phase 3 IAP312 study of Zalviso® (sufentanil sublingual tablet
system), an investigational product candidate being developed for
the management of moderate-to-severe acute pain in adult patients
in a hospital setting. IAP312 is a multicenter, open-label study
designed at the request of the Division of Anesthesia, Analgesia
and Addiction Products of the U.S. Food and Drug Administration
(FDA). The IAP312 study will enroll approximately 315 hospitalized,
post-operative patients who will use Zalviso to self-administer
sublingually tablets containing 15 micrograms of sufentanil as
often as once every 20 minutes for 24‑to-72 hours to manage
their moderate-to-severe acute pain. In addition to safety and
efficacy measures, IAP312 will collect information on device
usability, including any incidence of Zalviso's failure to dispense
medication as well as the incidence of misplaced or dropped
tablets.
Zalviso is a preprogrammed, patient-controlled analgesia (PCA)
system designed to dispense a non-invasive sublingual formulation
of sufentanil. Zalviso is currently approved by the European
Commission and is marketed by Grunenthal GmbH, AcelRx's European
commercial partner. Based on the Company's experience in previous
clinical trials and in Europe,
AcelRx has incorporated certain software and hardware revisions to
improve device usability and optimize system functionalities.
AcelRx has worked with its commercial supply chain partners to
produce the clinical materials for use in the IAP312 study.
"Anecdotal experience from Grunenthal's Zalviso launch that
began in April has been favorable, with patients and healthcare
workers providing positive feedback on the pain control offered by
sublingual sufentanil," commented Howie Rosen, AcelRx's chief
executive officer. "We look forward to conducting the IAP312 study
and submitting the findings to the FDA so that they may consider
the product for approval here in the U.S. We will provide an
update on study duration once we are further along with
enrollment."
Three Phase 3 studies for Zalviso in a total of 768 patients
have been completed to date: IAP309, IAP310 and IAP311, detailed
information for which may be found on www.clinicaltrials.gov. In
brief, IAP309 was a Phase 3 open-label, active comparator
study, in which Zalviso was shown to be non-inferior (p<0.001),
as well as superior (p=0.007), to intravenous (IV) PCA morphine
based on the primary endpoint of Patient Global Assessment method
of pain control comparison over the 48-hour trial period (PGA48).
IAP310 and IAP311 were Phase 3 double-blind, placebo-controlled
studies in which patients treated with Zalviso to manage their
post-operative pain reported a greater summed pain intensity
difference to baseline over 48 hours (SPID48, the primary endpoint)
compared to placebo-treated patients (p=0.001 and p<0.001,
respectively). The most common adverse events experienced by
patients using Zalviso in these clinical studies were nausea,
pyrexia (fever) and vomiting.
"We designed Zalviso to have characteristics that would offer
patients and healthcare providers benefits over IV morphine, the
current standard of care for the treatment of moderate-to-severe
acute pain in hospitalized patients," concluded Dr. Pamela Palmer,
AcelRx's co-founder and chief medical officer. "The initiation of
IAP312 is an important milestone, as it represents what we expect
to be the last step in the Zalviso clinical development program,
bringing a product that we believe can offer patients a new option
for treating their moderate-to-severe acute pain, closer to
market."
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. The Company's
late-stage pipeline includes ARX-04 (sufentanil sublingual tablet,
30 mcg), designed for the treatment of moderate-to-severe acute
pain in medically supervised settings; and Zalviso® (sufentanil
sublingual tablet system), designed for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting. Zalviso delivers 15 mcg sufentanil sublingually through a
non-invasive delivery route via a pre-programmed,
patient-controlled analgesia device. Zalviso is approved in the EU
as well as Norway, Iceland, and Liechtenstein and is investigational and in
late-stage development in the U.S. Grunenthal Group holds the
rights for Zalviso in Europe and
Australia, while AcelRx retains
all other world-wide rights.
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,
ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso®
(sufentanil sublingual tablet system), including the ARX-04
clinical trial results; anticipated submission of the New Drug
Application (NDA) for ARX-04 to the U.S. Food and Drug
Administration (FDA); AcelRx's pathway forward towards gaining
approval of Zalviso in the U.S.; the anticipated timing, design and
results of IAP312 clinical trial for Zalviso; anticipated
resubmission of the Zalviso NDA to the FDA; and the therapeutic and
commercial potential of AcelRx's product candidates, including
potential market opportunities for ARX-04 and Zalviso. 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' ARX-04 development program, including
anticipated submission of the ARX-04 NDA and the fact that the FDA
may dispute or interpret differently clinical results obtained to
date from the Phase 3 studies of ARX-04; AcelRx's ability to
successfully execute the pathway towards a resubmission of the
Zalviso NDA, including the successful completion of the IAP312
clinical study for Zalviso; any delays or inability to obtain and
maintain regulatory approval of its product candidates including
ARX-04 in the United States and
Europe, and Zalviso in
the United States; the uncertain
clinical development process, including adverse events; the risk
that planned clinical trials, including IAP312 for Zalviso, may not
have an effective clinical design, enroll a sufficient number of
patients, or be completed on schedule, if at all; the success, cost
and timing of all development activities and clinical trials,
including the IAP312 clinical study for Zalviso; 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
July 29, 2016. 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.