REDWOOD CITY, Calif.,
April 13, 2017 /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 that Grunenthal, the
company's licensee for ZALVISO® in Europe and Australia, has published two analyses of
patient-controlled analgesia (PCA) systems in the peer-reviewed
journal, Current Medical Research and Opinion. These
manuscripts were based on a systematic literature review of
efficacy, safety and tolerability results from studies that were
published between 2004 and 2015 of three routes of PCA
administration: intravenous (IV) PCA with morphine, transdermal PCA
with fentanyl and sublingual sufentanil delivered via ZALVISO.
Patients enrolled in these studies had moderate-to-severe acute
post-operative pain following surgical procedures such as knee or
hip replacement, open abdominal, cardiac, brain, lower limb
orthopedic and chest surgery.
"We know that severe pain after surgery contributes to the
development of chronic pain. It is therefore critical that
post-operative acute pain is addressed so that patients may regain
mobility, which may in turn facilitate their recovery, reduce
length of stay and lessen the risk of complications," commented Dr.
Pamela Palmer, co-founder and chief medical officer of AcelRx and a
co-author on the Current Medical Research and Opinion
papers. "While the analyses in these two papers were conducted via
literature review and therefore convey only indirect findings, the
conclusions may still be useful to healthcare providers in their
assessment of patient-controlled analgesia options."
Details on the publications:
Katz P, Takyar S, Palmer
P, Liedgens H. Indirect treatment comparison of two non-invasive
patient-controlled analgesia treatments for acute post-operative
pain management. Curr Med Res Opin. 2017 Mar 15:1-8.
Katz P, Takyar S, Palmer P, Liedgens H. Sublingual, transdermal
and intravenous patient-controlled analgesia for acute
post-operative pain: systematic literature review and mixed
treatment comparison. Curr Med Res Opin. 2017 Mar 20:1-12.
About the Journal:
Current Medical Research and
Opinion (CMRO) is a MEDLINE-indexed, peer-reviewed,
international journal for the rapid publication of original
research on new and existing drugs and therapies, Phase II-IV
studies, and post-marketing investigations. The aim of CMRO is to
provide ethical, unbiased quality content that is validated by
rigorous peer review. CMRO aims to serve the information needs of
the clinical medicine community, to help translate medical advances
into patient care and be a leader in transparency and disclosure by
facilitating a collaborative and honest approach to
publication.
About ZALVISO® (Sufentanil Sublingual Tablet
System)
ZALVISO is a drug/device combination product
designed to deliver 15 mcg sufentanil, a high therapeutic index
opioid, formulated in a proprietary non-invasive sublingual dosage
form via a novel hand-held, pre-programmed, patient-controlled
analgesia system. ZALVISO is approved in the European Union where a
commercial launch has begun by Grunenthal Group GmbH, AcelRx's
licensee for Europe and
Australia. ZALVISO remains an
investigational product candidate in the
United States, where it is currently being assessed in the
Phase 3 IAP312 study, which will collect information on device
usability, as well as the incidence of misplaced or dropped
tablets.
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. A New Drug
Application (NDA) for DSUVIA™ (sufentanil sublingual tablet, 30
mcg), known as ARX-04 outside the United
States, with a proposed indication for the treatment of
moderate-to-severe acute pain in medically supervised settings, has
been accepted for filing by the FDA in the United States. In the EU, the European
Medicines Agency (EMA) has notified the Company that the ARX-04
(sufentanil sublingual tablet, 30 mcg) Marketing Authorisation
Application (MAA) has passed validation, and that the scientific
review of the MAA is underway.
The Company's follow on product candidate, ZALVISO® (sufentanil
sublingual tablet system), designed for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting, is currently enrolling patients in a Phase 3 clinical
trial, IAP312. 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
and is investigational and in late-stage development in the U.S.
Grunenthal Group holds the rights for ZALVISO in Europe, where a commercial launch has
begun.
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; the potential approval of the
DSUVIA NDA by the FDA; the the European Medicines Agency (EMA)
scientific review of the ARX-04 Marketing Authorisation Application
(MAA); the DSUVIA and ARX-04 clinical trial results; AcelRx's
pathway forward towards gaining approval of ZALVISO in the U.S.,
including successful completion of the IAP312 clinical study for
ZALVISO; and the therapeutic and commercial potential of AcelRx's
product candidates. 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 FDA review of the DSUVIA NDA
and the EMA review of the ARX-04 MAA, including possibility that
the FDA or EMA may dispute or interpret differently clinical
results obtained from the DSUVIA or ARX-04 Phase 2 and 3 studies;
the ZALVISO development program, including successful completion of
IAP312 and 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; the success and timing of all development
activities and clinical trials; and other risks detailed in the
"Risk Factors" and elsewhere in AcelRx's U.S. Securities and
Exchange Commission filings and reports, including its Annual
Report on Form 10-K filed with the SEC on March 3, 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.