REDWOOD CITY, Calif.,
Nov. 4, 2015 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute pain, will be presenting at ObesityWeek 2015 an analysis from
three Phase 3 studies showing that Zalviso™ (sufentanil sublingual
tablet system 15 mcg) provides a faster onset of pain relief in
obese (BMI ≥ 30 kg/m2) post-surgical patients than
intravenous (IV) patient-controlled analgesia (PCA) with morphine.
Specifically, patients who self-administered Zalviso experienced
statistically significantly improved pain relief when compared to
self-administered IV morphine as measured by pain intensity
difference to baseline (PID). Significant differences in PID
were observed as early as 45 minutes after the first dose
(p<0.05), a trend that continued until six hours after the
initial dose (p<0.001), after which time PID scores equilibrated
between the two groups.
"Both of our lead products, Zalviso and ARX-04 (a
double-strength dose of sublingual sufentanil 30 mcg administered
by a nurse) benefit from sufentanil's lipophilic nature," said Dr.
Pamela Palmer, AcelRx Co-founder and
Chief Medical Officer. "Lipophilic, or fat-soluble drugs,
typically produce rapid drug uptake from mucosal tissues into the
plasma and then into the brain, promoting minimal delay between
dosing and pain relief. Nurse-administered ARX-04 dosing is
designed to address more short-term moderate-to-severe pain
treatment. For 2 or 3-day inpatient stays, Zalviso allows patients
to self-titrate regardless of body mass so they are able to achieve
their individualized pain relief goals without the need for
time-consuming dose-adjustments from hospital staff."
Results of the sub-group analysis presented by AcelRx also show
that obese patients who administered Zalviso experienced
statistically fewer adverse events than did those receiving IV PCA
morphine. While overall adverse event rates were comparable,
incidence rates of anemia, leukocytosis (increase in white blood
cells), vomiting, hypoalbuminemia (decrease in albumin levels),
hyponatremia (decrease in sodium levels), urinary retention and
pruritus (itching) were all significantly lower in the Zalviso arm
compared to the morphine arm (p≤0.05).
Dr. Palmer continued, "We believe that the non-invasive route of
administration of Zalviso and ARX-04 sets these drugs apart from
analgesics requiring an IV line which can be associated with
increased infection risk and decreased mobility. Obese
postoperative patients suffer from an increased physiological risk,
as well as difficult IV access, and we want to make every effort to
keep these patients ambulatory in order to avoid post-operative
complications, such as partial lung collapse, deep vein thrombosis,
and pulmonary embolism."
Complete results titled "Efficacy and Safety of the Sufentanil
Sublingual Tablet System (SSTS) in Class I and II Obese Patients:
The Effect of BMI on Analgesic Response" will be presented during
ObesityWeek 2015, being held in Los
Angeles, CA, from November 2-6,
2015. ObesityWeek is a unique, international event
with more than 5,200 attendees from 73 countries focused on the
basic science, clinical application, surgical intervention and
prevention of obesity. By combining both the American Society for
Metabolic & Bariatric Surgery (ASMBS) and The Obesity Society
(TOS) annual meetings, ObesityWeek brings together world-renowned
experts in obesity to share innovation and breakthroughs in science
unmatched around the globe.
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. 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, a high therapeutic index
opioid, sublingually through a disposable, pre-filled, single-dose
applicator. AcelRx has reported positive results from the pivotal
Phase 3 SAP301 ambulatory surgery study, and has advanced
ARX-04 into a study (SAP-302) in emergency room patients. Zalviso
delivers 15 mcg sufentanil sublingually through a non-invasive
delivery route via a pre-programmed, patient-controlled analgesia
device. In response to the New Drug Application (NDA) AcelRx
submitted to the U.S. Food and Drug Administration (FDA) seeking
approval for Zalviso, AcelRx received a Complete Response Letter
(CRL) on July 25, 2014. The FDA has
requested an additional clinical study and the Company is working
with the FDA regarding the resubmission of the Zalviso NDA and
initiation of a clinical study to support resubmission.
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,
including the process and timing of anticipated future development
of Zalviso and ARX-04; anticipated results and timing of the
completion of the SAP302 study for ARX-04; AcelRx's plans to seek a
pathway forward towards gaining approval of Zalviso in the United States; and anticipated
resubmission of the Zalviso NDA to the FDA, including the scope and
timing of resubmission. These forward-looking statements are based
on AcelRx's current expectations and inherently involve significant
risks and uncertainties. AcelRx's 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:
any delays or inability to obtain and maintain regulatory approval
of its product candidates, including Zalviso and ARX-04; its
ability to successfully design and complete the additional clinical
study requested by the FDA to support resubmission of the Zalviso
NDA; its ability to timely resubmit the Zalviso NDA to the FDA and
to receive regulatory approval for Zalviso; the fact that the FDA
may dispute or interpret differently positive clinical results
obtained to date from the pivotal Phase 3 SAP301 ambulatory surgery
study of ARX-04; its ability to complete Phase 3 clinical
development of ARX-04; the success, cost and timing of all product
development activities and clinical trials, including the SAP302
ARX-04 trial; 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 November 3,
2015. 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.