AcelRx Pharmaceuticals Announces Publication Concluding that Sublingual Sufentanil Tablets Provide the Opportunity to Non-Invasively and Rapidly Treat Moderate-To-Severe Acute Pain in a Monitored Setting
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.