scPharmaceuticals Announces FDA Approval of

FUROSCIX demonstrated 99.6% bioavailability and produced comparable diuresis and natriuresis in comparison with intravenous furosemide

Commercial launch deliberate in Q1 2023

BURLINGTON, Mass., Oct. 10, 2022 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical firm targeted on growing and commercializing merchandise which have the potential to optimize the supply of infused therapies, advance affected person care, and cut back healthcare prices, in the present day introduced that the U.S. Food and Drug Administration (FDA) has authorized FUROSCIX® (furosemide injection), a proprietary formulation of furosemide delivered by way of an On-Body Infusor for the therapy of congestion because of fluid overload in adults with New York Heart Association Class II/III persistent coronary heart failure. FUROSCIX isn’t indicated for emergency conditions or in sufferers with acute pulmonary edema. FUROSCIX Infusor will ship solely an 80-mg dose. FUROSCIX is the primary and solely FDA-approved subcutaneous loop diuretic that delivers IV equal diuresis at residence by way of the FUROSCIX Infusor.

“Congestion due to worsening heart failure is one of the most common causes of hospital admissions in patients over 65, and today’s approval of FUROSCIX represents an important treatment advancement for the over seven million heart failure patients in the U.S. that will be able to self-administer IV equivalent diuresis at home,” mentioned John Tucker, President and Chief Executive Officer of scPharmaceuticals. “We are preparing to optimize commercialization efforts to offer FUROSCIX to patients in the first quarter of next year with the goal of driving rapid patient adoption to meet the needs of the $5.9 billion addressable market in the U.S.”

IV equivalence was established in a medical examine wherein FUROSCIX demonstrated 99.6% bioavailability (90% CI: 94.8%-104.8%) and 8-hour urine output of 2.7 L which was just like topics receiving intravenous furosemide. FUROSCIX isn’t indicated to be used in emergency conditions or in sufferers with acute pulmonary edema. The On-Body Infusor will ship solely an 80-mg dose of FUROSCIX.

“As we move towards commercialization, we have compiled a body of evidence demonstrating the value proposition of FUROSCIX across healthcare stakeholders,” mentioned John Mohr, Pharm.D., Senior Vice President, Clinical Development and Medical Affairs of scPharmaceuticals. “The totality of clinical and pharmacoeconomic data that we have generated to date supports an opportunity to shift the treatment paradigm of how heart failure patients with congestion are treated and has the potential to become a new standard of care.”

FUROSCIX permits subcutaneous administration at residence by the affected person or a caregiver with the use of the FUROSCIX On-Body Infusor. The On-Body Infusor for FUROSCIX was developed using West Pharmaceutical Services’ proprietary SmartDose®¹ On-Body Drug Delivery expertise. Once the pre-filled cartridge is inserted into the pre-programmed single-use On-Body Infusor for FUROSCIX and connected to the stomach, the gadget is activated with the press of a button to ship an 80-mg dose over 5 hours.

“This marks a tremendous opportunity to improve the at-home management of worsening congestion in patients with heart failure who display reduced responsiveness to oral diuretics and require administration of intravenous diuretics, which typically requires admission to the hospital,” mentioned William T. Abraham, M.D., Professor of Internal Medicine (Cardiology), Physiology and Cell Biology and College of Medicine Distinguished Professor at The Ohio State University and scPharmaceuticals Board member. “The FDA’s approval of FUROSCIX is significant and will allow patients to be treated outside of the hospital setting, and I look forward to incorporating it into my own practice as quickly as possible.” 

FUROSCIX® (furosemide injection) 80 mg/10 mL for subcutaneous use

INDICATIONS AND LIMITATIONS OF USE

FUROSCIX® is indicated for the therapy of congestion because of fluid overload in grownup sufferers with New York Heart Association (NYHA) Class II and Class III persistent coronary heart failure.

FUROSCIX isn’t indicated to be used in emergency conditions or in sufferers with acute pulmonary edema. The On-Body Infusor will ship solely an 80-mg dose of FUROSCIX.

IMPORTANT SAFETY INFORMATION

FUROSCIX is contraindicated in sufferers with anuria, sufferers with a historical past of hypersensitivity to furosemide or medical adhesives and in sufferers with hepatic cirrhosis or ascites.

Furosemide could trigger fluid, electrolyte, and metabolic abnormalities, significantly in sufferers receiving increased doses, sufferers with insufficient oral electrolyte consumption, and in aged sufferers. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid must be monitored steadily throughout furosemide remedy.

Excessive diuresis could trigger dehydration and blood quantity discount with circulatory collapse and probably vascular thrombosis and embolism, significantly in aged sufferers.

In sufferers with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte steadiness could precipitate hepatic encephalopathy and coma. Treatment in such sufferers is finest initiated within the hospital.

Furosemide may cause dehydration and azotemia. If rising azotemia and oliguria happen throughout therapy of extreme progressive renal illness, furosemide must be discontinued.

Cases of tinnitus and reversible or irreversible listening to impairment and deafness have been reported with furosemide. Reports normally point out that furosemide ototoxicity is related to fast injection, extreme renal impairment, the use of increased than really helpful doses, hypoproteinemia or concomitant remedy with aminoglycoside antibiotics, ethacrynic acid, or different ototoxic medication.

In sufferers with extreme signs of urinary retention (as a result of of bladder emptying issues, prostatic hyperplasia, urethral narrowing), the administration of furosemide may cause acute urinary retention associated to elevated manufacturing and retention of urine. These sufferers require cautious monitoring, particularly throughout the preliminary phases of therapy.

For extra particulars, please learn the complete Prescribing Information at FUROSCIX.com/prescribing-information.pdf and Instructions for Use at FUROSCIX.com/instructions-for-use.pdf. 

About scPharmaceuticals

scPharmaceuticals is a pharmaceutical firm targeted on growing and commercializing merchandise which are designed to cut back healthcare prices and enhance well being outcomes. The Company develops, internally and thru strategic partnerships, modern merchandise and options that purpose to increase and advance the outpatient care of choose acute circumstances. The Company’s lead applications deal with the subcutaneous, self-administration of IV-strength remedies in coronary heart failure and infectious illness. scPharmaceuticals is headquartered in Burlington, MA. For extra info, please go to www.scPharmaceuticals.com.

Forward-Looking Statements

This press launch incorporates “forward-looking statements” inside the that means of the Private Securities Litigation Reform Act of 1995. All statements contained on this press launch that don’t relate to issues of historic reality must be thought of forward-looking statements, together with, however not restricted to, statements concerning the importance and potential influence of the outcomes of medical trials and medical knowledge; the interpretation and analyses of the outcomes from medical trials; expectations concerning the potential market influence of FUROSCIX; the preparation and timing of industrial launch and the success of such commercialization; and the potential advantages, anticipated prices and future plans and expectations for FUROSCIX. Any forward-looking statements on this press launch are based mostly on administration’s present expectations of future occasions and are topic to a quantity of dangers and uncertainties that might trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements. These dangers and uncertainties embody, however aren’t restricted to, the danger that outcomes of a medical examine don’t essentially predict remaining outcomes and that a number of of the medical outcomes could materially change following extra complete opinions of the info, and as extra affected person knowledge develop into accessible, the danger that outcomes of a medical examine are topic to interpretation and extra analyses could also be wanted and/or could contradict such outcomes, the danger of the flexibility of the FUROSCIX On-Body Infusor to appropriately ship remedy, the receipt of regulatory approval for any of our product candidates or, if authorized, the profitable commercialization of such merchandise, the danger of cessation or delay of any of the continued or deliberate medical trials and/or our growth of our product candidates, the danger that the outcomes of beforehand performed research won’t be repeated or noticed in ongoing or future research involving our product candidates, dangers associated to manufacturing and high quality assurances processes, and the danger that the present COVID-19 pandemic will influence the Company’s gadget validation, drug stability testing, and different operations. For a dialogue of these and different dangers and uncertainties, and different necessary components, any of which might trigger our precise outcomes to vary from these contained within the forward-looking statements, see the part entitled “Risk Factors” in Company’s Annual Report on Form 10-Ok for the yr ended December 31, 2021 on file with the Securities and Exchange Commission, accessible on the Securities and Exchange Commission’s web site at www.sec.gov, in addition to discussions of potential dangers, uncertainties and different necessary components within the Company’s subsequent filings with the Securities and Exchange Commission. All info on this press launch is as of the date of the discharge, and the Company undertakes no responsibility to replace this info except required by legislation.

Katherine Taudvin
scPharmaceuticals Inc., 781-301-6706
[email protected]

Investors:
Hans Vitzthum
LifeSci Advisors, 617-430-7578
[email protected] 

¹ SmartDose® and the exterior product configuration of West’s SmartDose® drug supply platform are the registered trademark and mental property of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc., within the United States and different international locations.