BURLINGTON, Mass.--(BUSINESS WIRE)--scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced it will host a key opinion leader (KOL) call on FUROSCIX® (furosemide) 80mg/10mL for subcutaneous administration, an investigational subcutaneous diuretic therapy for the outpatient treatment of congestion in patients with heart failure, on Tuesday, September 29, 2020 at 11am Eastern Time.
The call will feature a presentation by Key Opinion Leaders (KOLs) Dan Bensimhon, MD (Cone Health) and Nihar Desai, MD, MPH (Yale School of Medicine) who will discuss the current treatment landscape and unmet medical need in treating patients with worsening heart failure due to congestion. Dr. Bensimhon and Dr. Desai will be available to answer questions at the conclusion of the event.
The scPharmaceuticals management team will also discuss the FUROSCIX® development plan. FUROSCIX® is an investigational, proprietary formulation of furosemide that is administered by subcutaneous infusion via a wearable on-body, drug delivery system, for outpatient self-administration.
scPharmaceuticals has filed a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval of FUROSCIX® for the treatment of congestion due to fluid overload in adult patients with worsening New York Heart Association (NYHA) Class II and Class III heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization. scPharmaceuticals recently announced that its resubmission has been accepted for review and assigned a Prescription Drug User-Fee Act (PDUFA) target action date of December 30, 2020.
Dan Bensimhon, MD is a Duke-trained advanced heart failure cardiologist who serves as the Medical Director of the Advanced Heart Failure & Mechanical Circulatory Support Program at Cone Health, a six-Hospital system in central North Carolina. Dan is a member of the Education Committee of the Heart Failure Society of America and is on the Board of the Lebauer-Brodie CV Research Foundation.
His current research interest is developing Heart Failure-at-home networks. He serves as a consultant and active member of multiple scientific advisory boards. He is also the Medical Director for Urgent Care services with InTouch Health - a leading telemedicine platform and works actively with several large home health organizations developing Heart Failure-at-home protocols and services.
Nihar R. Desai, MD, MPH is an Associate Professor of Medicine and Associate Chief of the Section of Cardiovascular Medicine at Yale University School of Medicine, an Investigator at the Center for Outcomes Research and Evaluation, and Medical Director for Value Innovation at the Yale New Haven Health System. His interests focus on cardiovascular health services and comparative effectiveness research, examining patterns of care, identifying opportunities to improve clinical outcomes, and evaluating the impact of novel care delivery systems on cost and quality. In addition, he serves as a clinical consultant on the CMS acute myocardial infarction, heart failure, and coronary artery bypass graft surgery readmission and mortality measures. He graduated with highest honors from Lehigh University before completing an internship in the Clinton White House. He then attended the University of Connecticut School of Medicine where he received his Doctorate in Medicine and the Harvard School of Public Health where he received his Master’s in Public Health. Dr. Desai completed his residency training in Internal Medicine as well as his clinical fellowship in Cardiovascular Medicine at Brigham and Women’s Hospital and Harvard Medical School. He then completed a research fellowship at the TIMI Study Group with Dr. Eugene Braunwald. His scholarly work has been published in New England Journal of Medicine, Journal of the American Medical Association, Circulation, and the Journal of the American College of Cardiology.
scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.