Experts from the Uniformed Services University of the Health Sciences conclude that future battlefield medicine efforts should focus on newer analgesics like DSUVIA® across military settings and establish protocols for their implementation
HAYWARD, Calif., Aug. 25, 2022 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that an abstract entitled, "Evolution Of Opioid Analgesia On The Battlefield For Moderate-to-Severe Acute Pain" (abstract # A4123) was accepted for e-Abstract presentation at the ANESTHESIOLOGY® 2022 annual meeting, being held October 21-25, 2022 in New Orleans, LA.
"The DSUVIA sufentanil sublingual tablet, or SST, is the only transmucosal analgesic that is approved for the management of moderate-to-severe acute pain in patients who are opioid-naive, such as our soldiers in the military," stated Vince Angotti, Chief Executive Officer of AcelRx. "Morphine has been the primary analgesic on the battlefield since the 19th century, however, morphine has many limitations, including a narrow therapeutic index. Over the past few decades, an oral transmucosal fentanyl lozenge, indicated only for cancer breakthrough pain, was introduced as an off-label alternative to injectable morphine on the battlefield. As stated in the abstract, there has been a high incidence of side effects with the use of the lozenge, as well as the risk for addiction and misuse."
Mr. Angotti continued, "DSUVIA is an alternative analgesic with many potential advantages for use on the battlefield. The Department of Defense, or DoD, recognized the therapeutic benefits of potent opioids in acute trauma settings and aimed to improve upon their application for the battlefield setting when providing funding for the development of DSUVIA. We continue to work with critical decision-makers at the DoD to facilitate the broad roll-out of DSUVIA for our U.S. military."
In the abstract, the authors (Kim, et al.), all from Uniformed Services University of the Health Sciences, highlight the advantages of SST on the battlefield, which include:
- High therapeutic index
- No active metabolites
- Analgesic onset within 15 minutes
- Maintains therapeutic levels for 3 hours
- No association with cognitive impairment
The authors conclude that, "future work should aim to improve opioid products for the battlefield, discover non-opioid analgesic options, and establish optimal drug administration protocol in trauma settings".
E-Abstracts will be presented virtually and made available to registrants throughout the entire meeting from Saturday, October 22 (7:00 a.m. US Central Time) to Tuesday, October 25, 2022 (3:00 p.m. U.S. Central Time). The abstracts will remain available and open to meeting attendees for three months after the meeting.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA®, known as DZUVEO® in Europe, is indicated for use in adults in certified medically supervised healthcare settings, 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. DZUVEO has been approved by the European Medicines Agency and AcelRx's European commercialization partner, Aguettant, will market the drug in Europe.
This release is intended for investors only. For more information, including important safety information and black box warning for DSUVIA, 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), approved 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 several product candidates. The Company's product candidates include: two developmental pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the U.S. from Aguettant; Niyad™, a developmental device for use as a regional anticoagulant for the extracorporeal circuit; LTX-608, for the potential treatment of COVID-19, disseminated intravascular coagulation, acute respiratory distress syndrome and acute pancreatitis; and Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg), an investigational product in the U.S. being developed as an innovatively designed patient-controlled analgesia (PCA) system for reduction of moderate-to-severe acute pain in medically supervised settings.
This release is intended for investors only. For additional information about AcelRx, please visit www.acelrx.com.
About Uniformed Services University of the Health Sciences
The Uniformed Services University (USU) of the Health Sciences, founded by an act of Congress in 1972, is the nation's federal health sciences university and the academic heart of the Military Health System. USU students are primarily active-duty uniformed officers in the Army, Navy, Air Force and Public Health Service who receive specialized education in tropical and infectious diseases, TBI and PTSD, disaster response and humanitarian assistance, global health, and acute trauma care. USU also has graduate programs in oral biology, biomedical sciences and public health committed to excellence in research. The University's research program covers a wide range of areas important to both the military and public health. For more information about USU and its programs, visit www.usuhs.edu.
About the ANESTHESIOLOGY 2022 Annual Meeting
The ANESTHESIOLOGY Annual Meeting is the marquee annual event for the American Society of Anesthesiologists®. Founded in 1905, the American Society of Anesthesiologists is an educational, research and scientific association of physicians organized to raise the standards of the medical practice of anesthesiology and to improve patient care. As of 2021, the organization included more than 55,000 national and international members.
This press release contains forward-looking statements, including, but not limited to, statements related to the potential adoption and benefits of DSUVIA for use in military settings. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "potential," "believe," "expect," "expected," "anticipate," "may," "will," "should," "seek," "approximately," "intends," "plans," "estimates," "benefits," or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to AcelRx's product development activities and ongoing commercial business operations; (ii) risks related to the ability of AcelRx to implement its development plans, forecasts and other business expectations; (iii) risks related to unexpected variations in market growth and demand for AcelRx's commercial and developmental products and technologies; and (iv) risks relating to our ability to obtain regulatory approvals for our developmental product candidates. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in AcelRx's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the Securities and Exchange Commission (SEC) and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in AcelRx's most recent annual, quarterly or current report as filed or furnished with the SEC. AcelRx's SEC reports are available at www.acelrx.com under the "Investors" tab. Except to the extent required by law, AcelRx undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
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