REDWOOD CITY, Calif.,
April 18, 2018 /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, announced the publication of an analysis of
the pharmacokinetic characteristics of sublingually administered
tablets containing 15 or 30 mcg of sufentanil in a special
"Frontiers in Opioid Pharmacotherapy" edition of the peer-reviewed
journal, Anesthesiology. The manuscript reports on the
results of pharmacokinetic analyses using blood sampled from both
healthy subjects and surgical patients in AcelRx clinical trials in
order to determine the effects of weight, age, sex, and organ
impairment on apparent clearance of sufentanil from plasma
following tablet administration.
The study concluded that sublingual sufentanil tablets provide
the opportunity to non-invasively and rapidly treat
moderate-to-severe pain in a monitored setting. Following dosing of
the 30 mcg sufentanil sublingual tablet, therapeutic sufentanil
plasma concentrations were reached within 30 minutes and remained
above this level for approximately 3 hours, consistent with the
onset and duration of analgesia observed in the clinical trials.
The results also indicated that drug clearance, which increased
slightly with weight and decreased slightly with age, was not
affected by sex of the patient or by hepatic or renal
impairment.
"The current standard of care to treat moderate-to-severe acute
pain via IV opioid administration can delay pain relief or require
unnecessary IV access for patients," commented Dr. Dennis Fisher, lead author of the study.
"The onset and duration of therapeutic sufentanil plasma
concentrations matches nicely with the analgesic needs in
short-term medically monitored settings, such as the emergency room
or ambulatory surgery centers."
Details on the publications:
Fisher D, Chang P, Wada
R, Dahan A, Palmer P. Pharmacokinetic Properties of a Sufentanil
Sublingual Tablet Intended to Treat Acute Pain.
Anesthesiology. 2018 May.
About the Journal:
Anesthesiology founded in
1940, leads the world in publication of peer-reviewed novel
research that transforms clinical practice and fundamental
understanding in anesthesiology: the practice of perioperative,
critical care, and pain medicine. Anesthesiology is the
official journal of the American Society of Anesthesiologists but
operates with complete editorial autonomy. With an independent and
internationally recognized Editorial Board, the Journal leads the
specialty in promotion of original research by providing immediate
open access to highlighted articles and free access to all
published articles 6 months after publication, supported by an
active press release program. Anesthesiology is committed to
publishing and disseminating the highest quality work to inform
daily clinical practice and transform the practice of medicine in
our specialty.
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 two product candidates including 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, and Zalviso® (sufentanil sublingual tablet
system, SST system, 15 mcg) being developed as an innovatively
designed patient-controlled analgesia (PCA) system for reduction of
moderate-to-severe acute pain in medically supervised settings.
For additional information about AcelRx's clinical programs,
please visit www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.