REDWOOD CITY, Calif.,
Sept. 22, 2015 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX) (AcelRx) announced today that
the European Commission (EC) has approved Zalviso™ (15 micrograms
sufentanil sublingual tablets) for the management of acute
moderate-to-severe post-operative pain in adult patients. The
marketing authorization is granted for the 28 EU member states as
well as for the European Economic Area (EEA) countries,
Norway, Iceland and Liechtenstein. Zalviso is a system combining a
drug and a device designed to deliver a sublingual tablet
formulation of sufentanil 15 mcg via a proprietary, pre-programmed,
non-invasive, patient-controlled analgesia (PCA) device. Grunenthal
Group, AcelRx's licensee in Europe
and Australia, expects the product
to be available to Western European patients in the first half of
2016.
"This is a significant event for AcelRx. Not only is this the
Company's first marketing approval, but it represents the
successful development and commercialization of a product that we
believe will provide a new way for physicians and their patients to
treat acute moderate-to-severe post-operative pain using an
innovative delivery method," stated Howie
Rosen, interim chief executive officer of AcelRx
Pharmaceuticals. "Our partner Grunenthal will be working with the
member states of the EU and EEA to ensure that Zalviso is made
available to those patients who would benefit from an effective and
reliable solution for their moderate-to-severe post-surgical
pain."
Zalviso is designed to offer sustained (for up to 72 hours) and
reliable pain relief for acute moderate-to-severe post-operative
pain. In a Phase 3 clinical trial in patients who had undergone
major joint replacement or open abdominal surgery, a higher
percentage of study participants who self-administered Zalviso over
a 48-hour period rated the method of pain control "good" or
"excellent" compared to those using intravenous (IV) morphine PCA
(p=0.007). Moreover, patients surveyed in this study rated their
overall ease of care (p<0.001) and overall satisfaction
(p=0.004) with Zalviso as higher than with IV morphine PCA. Zalviso
was also rated by nurses to provide higher treatment satisfaction
(p<0.001) and overall ease of care (p=0.017) compared with IV
morphine PCA. Adverse events reported in the study were generally
mild or moderate in nature and similar in both placebo and
treatment groups, however fewer patients using Zalviso™ experienced
oxygen desaturation episodes < 95% (p=0.028).
Dott. Alberto Grua, chief
commercial officer Europe,
Australia, North America & Global Product Supply (CCO
EU, AUS, NA & GPS) from Grunenthal, adds, "We are delighted to
bring a new, innovative way to manage post-operative pain to
European healthcare professionals and patients. By combining the
benefits of patient-controlled analgesia with those of a
non-invasive route of administration, Zalviso offers a unique
solution to address unmet needs of adult patients suffering from
acute moderate-to-severe post-operative pain."
On an annual basis, there are 19 million surgical procedures
with associated acute moderate-to-severe post-operative pain in the
European Union. A recent German survey in patients after surgery
has shown that 55% of all patients are not satisfied with their
treatment for post-operative pain1. Even more so, 30%
mention that their pain management has been inadequately effective
[1 Maier C et al. Dtsch Arztebl Int. 2010; 107;
607-614].
About Zalviso
Zalviso is an innovative pre-programmed, non-invasive, handheld
system that allows hospital patients with acute moderate-to-severe
post-operative pain to self-dose with sufentanil sublingual
tablets, 15 mcg, to manage their pain. The system is designed
to help address certain problems associated with post-operative
analgesia, such as the drug-related side effects and delayed
analgesic effect of morphine, the invasive intravenous (IV) route
of delivery of current systems for patient-controlled analgesia
(PCA) and the complexity of infusion pumps used for IV PCA
delivery.
Grunenthal holds the rights for Zalviso in Europe and Australia while AcelRx retains all rights in
North America, Asia, Latin
America and Middle
East/Africa. Under the
terms of the collaboration, Grunenthal is responsible for
maintaining the regulatory approval for the drug product and all
commercial activities for Zalviso, in the Grunenthal territory.
AcelRx will be responsible for maintaining device regulatory
approval in the Grunenthal territory, as well as manufacturing and
supply of Zalviso to Grunenthal for commercial sales and clinical
trials.
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 acute pain. In the US, the Company's
late-stage pipeline includes ARX-04 (sufentanil sublingual tablet,
30 mcg) for the treatment of moderate-to-severe acute pain in a
medically supervised setting; and Zalviso (sufentanil sublingual
tablet system) for the management of moderate-to-severe acute pain
in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil sublingual, a high therapeutic
index opioid, through a disposable, pre-filled, single-dose
applicator (SDA). AcelRx has reported positive results from the
pivotal Phase 3 SAP301 ambulatory surgery study, and will be
advancing ARX-04 into a study in emergency room patients in 2015.
Zalviso delivers 15 mcg sufentanil sublingual tablets 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 in late-stage development
in the U.S. In response to the New Drug Application (NDA) AcelRx
submitted to the U.S. Food and Drug Administration (FDA) seeking
approval for Zalviso, the Company received a Complete Response
Letter (CRL) on July 25, 2014. The
FDA has requested an additional clinical study prior to the
resubmission of the Zalviso NDA.
The Company has two additional pain treatment product
candidates, ARX-02 and ARX-03, which have completed Phase 2
clinical development. 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 timing of
any commercial launch of Zalviso; commercial success of Zalviso in
the market place, the therapeutic and commercial potential of
AcelRx Pharmaceuticals' product candidates, including Zalviso and
ARX-04, the process and timing of anticipated future development of
AcelRx's product candidates, including Zalviso and ARX-04, and any
regulatory approval of AcelRx product candidates in the US.
These forward-looking statements are based on AcelRx
Pharmaceuticals' current expectations and inherently involve
significant risks and uncertainties. AcelRx Pharmaceuticals' actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
related to: therapeutic and commercial potential for AcelRx
Pharmaceuticals' product candidates, including Zalviso and ARX-04;
ability to complete Phase 3 development for ARX-04, file an NDA and
to receive regulatory approval for ARX-04; the success, cost and
timing of all product development activities and clinical trials,
including the Phase 3 ARX-04 trial. AcelRx Pharmaceuticals
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.