REDWOOD CITY, Calif.,
Nov. 13, 2019 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for use in medically supervised settings,
today announced a publication analyzing pooled dosing and efficacy
data from use of the sufentanil sublingual tablet (SST) 30 mcg
among multiple demographic subgroups (age, sex, race, and body mass
index). This data, published in the Journal of
PeriAnesthesia Nursing, was analyzed to aid nurses in
understanding the effectiveness and duration of action of SST 30
mcg in the management of moderate-to-severe acute pain across a
variety of patient demographics.
In this study, patient characteristics were pooled from three
postoperative studies, and one open-label emergency department
study, while drug dosing and efficacy data were pooled from
postoperative studies. Mean drug doses administered from 0-12 hours
was 3.9 for SST 30 mcg, and was less frequent for older (≥65 years)
compared to younger patients but was similar among other subgroups.
Summed pain intensity difference to baseline over 12 hours (SPID12)
was higher (superior) in the SST 30-mcg group compared with placebo
across all demographic subgroups.
"We are pleased with the results of this analysis, particularly
that a single dosage-strength tablet has efficacy across all the
demographic subgroups," commented Dr. Pamela Palmer, AcelRx Chief Medical Officer. "An
important reason behind the development of DSUVIA® was to avoid
common opioid medication errors occurring with the clear injectable
opioids, which come in widely differing concentrations. Also, the
timely onset of analgesia and the duration of action allow DSUVIA
to fit nicely into the fast-paced environment of the post-surgical
recovery room and emergency departments."
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO™ in Europe, approved by the FDA in November 2018, is indicated for use in adults in
a certified medically supervised healthcare setting, such as
hospitals, surgical centers, and emergency departments, for the
management of acute pain severe enough to require an opioid
analgesic, and for which alternative treatments are inadequate.
DSUVIA was designed to provide rapid analgesia via a non-invasive
route and to eliminate dosing errors associated with intravenous
(IV) administration. DSUVIA is a single-strength solid dosage form
administered sublingually via a single-dose applicator (SDA) by
healthcare professionals. Sufentanil is an opioid analgesic
previously only marketed for IV and epidural anesthesia and
analgesia. The sufentanil pharmacokinetic profile when delivered
sublingually avoids the high peak plasma levels and short duration
of action observed with IV administration. The European Commission
approved DZUVEO for marketing in Europe in June
2018 and the Company is currently in discussions with
potential European marketing partners.
For more information, please visit www.DSUVIA.com.
About AcelRx Pharmaceuticals, Inc.
AcelRx
Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on the development and commercialization of innovative therapies
for use in medically supervised settings. AcelRx's proprietary,
non-invasive sublingual formulation technology delivers sufentanil
with consistent pharmacokinetic profiles. The Company has one
approved product in the U.S., DSUVIA®(sufentanil sublingual tablet,
30 mcg), known as DZUVEO in Europe, indicated for the management of acute
pain severe enough to require an opioid analgesic for adult
patients in certified medically supervised healthcare settings, and
one product candidate, Zalviso®(sufentanil sublingual tablet
system, SST system, 15 mcg), an investigational product in the
U.S., is being developed as an innovatively designed
patient-controlled analgesia (PCA) system for reduction of
moderate-to-severe acute pain in medically supervised settings.
DZUVEO and Zalviso are both approved products in Europe. For additional information about
AcelRx, please visit www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.