AcelRx Hosting Key Opinion Leader Webinar on Niyad™ Nafamostat Program
AcelRx Pharmaceuticals (NASDAQ: ACRX) announced a Key Opinion Leader webinar on May 4, 2022, at 1:00 PM EDT. The event will focus on the company's late-stage product candidate, Niyad™, a regional dialysis anticoagulant that has received FDA Breakthrough Device Designation. Niyad, already approved in Japan and Korea, aims to prevent clotting in dialysis machines. Experts Stuart Goldstein, MD, and Lakhmir Chawla, MD, will discuss the unmet medical need for such treatments in the U.S.
- Niyad™ has FDA Breakthrough Device Designation, accelerating its potential entry into the U.S. market.
- The product is already approved and used in Japan and Korea, indicating established efficacy.
- Key opinion leaders in acute kidney injury will provide expert insights during the webinar, enhancing company's credibility.
- No FDA-approved regional anticoagulants currently exist in the U.S., indicating possible market challenges.
- Dependence on expert opinion and limited current U.S. presence may limit market confidence.
Key Opinion Leaders participating will be Stuart Goldstein, MD, Cincinnati Children’s Hospital
and
Lakhmir Chawla, MD, former Chief of the Division of Intensive Care Medicine at the Washington
D.C. Veterans Affairs Medical Center
Webinar to be held Wednesday, May 4th at 1 pm EDT
HAYWARD, Calif., April 27, 2022 (GLOBE NEWSWIRE) -- 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 that it will host a Key Opinion Leader (KOL) webinar on Wednesday, May 4, 2022 at 1:00 pm Eastern Daylight Time. The webinar will discuss its recently acquired late-stage product candidate, Niyad™, a lyophilized form of nafamostat, a regional dialysis anticoagulant already approved in Japan and Korea. In the U.S., the Food and Drug Administration (FDA) has granted Niyad Breakthrough Device Designation status for injection into the extracorporeal circuit, the most commonly known being dialysis machines, to prevent clotting and ensure effective treatment is provided to the patient.
The webinar will feature presentations from two internationally renowned acute kidney injury (AKI) experts, Stuart Goldstein, MD, from Cincinnati Children’s Hospital, and Lakhmir Chawla, MD, former Chief of the Division of Intensive Care Medicine at the Washington D.C. Veterans Affairs Medical Center, who will discuss the unmet medical need for anticoagulation of the extracorporeal circuit. There are currently no FDA-approved regional anticoagulants for use in this setting. Niyad is being regulated as a device by the FDA and has been approved and used in Japan and Korea for several decades.
Nafamostat is a broad-spectrum, synthetic serine protease inhibitor, and, in addition to anticoagulant properties, it also has anti-inflammatory properties and potential anti-viral activities. LTX-608 (intravenous nafamostat) is a separate product candidate in the nafamostat program, with potential development by AcelRx for multiple conditions - including as a treatment for disseminated intravascular coagulation (DIC) and as an anti-viral treatment for COVID-19 and other indications.
A live question and answer session will follow. To register for the event, please click here.
About the KOLs
Stuart L Goldstein, M.D., is Professor of Pediatrics and Director, Center for Acute Care Nephrology at Cincinnati Children's Hospital Medical Center. He received his medical degree from Columbia University and completed both clinical and research fellowships in pediatric nephrology at the Children's Hospital in Boston, Massachusetts. Dr Goldstein is Founder and Principal Investigator for the Prospective Pediatric Acute Kidney Injury Research Group and has evaluated novel urinary AKI biomarkers in the pediatric critical care setting. He was one of two pediatric work group members for the KDIGI International AKI Guideline Work Group and has served on the KDOQI Hemodialysis Adequacy, Vascular Access and Pediatric Nutrition Guideline Work Groups. He has written over 300 journal articles, served as editor of two textbooks, and contributed book chapters to numerous texts including, Critical Care Nephrology, Evidence-Based Nephrology, Handbook of Dialysis Therapy, Management of Acute Kidney Problems, Pediatric Critical Care, Pediatric Nephrology, and Pediatric Nephrology in the ICU.
Lakhmir “Mink” Chawla, M.D., is currently the Chief Medical Officer of Silver Creek Pharmaceuticals. Previously, Dr. Chawla was CMO at La Jolla Pharmaceutical Company. While he was at LJPC, he oversaw the development and conduct of the Phase 3 ATHOS-3 trial. Prior to joining LJPC, Dr. Chawla was a Professor of Medicine at the George Washington University, where he had dual appointments in the Department of Anesthesiology and Critical Care Medicine and in the Department of Medicine, Division of Renal Diseases and Hypertension. Dr. Chawla was previously the Chief of the Division of Intensive Care Medicine at the Washington D.C. Veterans Affairs Medical Center. Dr. Chawla is an internationally renowned expert in the field of AKI and shock. He remains an active investigator in the fields of AKI biomarkers, AKI risk prediction, AKI therapeutics and chronic kidney disease caused by AKI.
Dr. Chawla is also the author of over 150 peer-reviewed publications and a recipient of the International Vicenza Award for Critical Care Nephrology; an award that recognizes individuals who have made seminal clinical research advancements that have significantly improved the care of critically ill patients with AKI and have been adopted worldwide.
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 several product candidates, including the following: 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; two pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the U.S. from Aguettant; Niyad™ (nafamostat), a regional anticoagulant for the extracorporeal circuit; and, LTX-608 for the potential treatment of COVID-19, disseminated intravascular coagulation, acute respiratory distress syndrome and acute pancreatitis. DZUVEO and Zalviso are both approved products in Europe. For additional information about AcelRx, please visit www.acelrx.com.
Investor Contacts:
AcelRx
Raffi Asadorian, CFO
650-216-3500
investors@acelrx.com
LifeSci Advisors
Kevin Gardner
LifeSci Advisors
617-283-2856
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
917-680-5608
ccalabrese@lifesciadvisors.com
FAQ
What is the purpose of AcelRx's webinar on May 4, 2022?
What is Niyad™ and its significance?
Who are the key speakers for the AcelRx webinar?
What is the current status of regional anticoagulants in the U.S.?
