Type C Meeting confirmed that FDA does not believe additional clinical safety, efficacy, or pharmacology studies will be required to support NDA resubmission and review
FDA confirmed that the resubmission would be under the current NDA
Company accelerates timeline and now expects resubmission of FUROSCIX NDA with the FDA by mid-year 2020
BURLINGTON, Mass., July 16, 2019 (GLOBE NEWSWIRE) — 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 received minutes from the Type C Guidance Meeting held on June 18, 2019, between the Company and the U.S. Food and Drug Administration (FDA), to discuss the Company’s New Drug Application (NDA) for FUROSCIX®, scPharmaceuticals’ lead program for the treatment of congestion in patients with heart failure.
As an outcome of the meeting, the FDA confirmed that it does not believe it will be necessary to conduct additional clinical safety, efficacy, or pharmacology studies as part of scPharmaceuticals’ NDA for FUROSCIX. The FDA further provided recommendations on the Company’s proposed device verification and validation plan for the FUROSCIX Infusor, which is currently underway. The FUROSCIX Infusor is West Pharmaceutical Services, Inc.’s (West) SmartDose® drug delivery system integrated with FUROSCIX. As a result of the Type C Meeting, scPharmaceuticals is accelerating its timeline and now expects resubmission of the FUROSCIX NDA with the FDA by mid-year 2020.
“We are encouraged by the most recent interactions with the FDA and believe we are in a position to resubmit FUROSCIX by mid-2020,” said John Tucker, president and chief executive officer of scPharmaceuticals. “With confirmation from the FDA that no additional clinical studies are required to resubmit our NDA, we now look to advance our planned human factors and device verification and validation work that is currently underway. We look forward to working with the FDA as we continue to develop FUROSCIX as a potential first-in-class treatment option for the millions of patients suffering from heart failure.”
FUROSCIX is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, subcutaneous injector with an integrated drug delivery system, for outpatient self-administration. FUROSCIX is being developed for treatment of congestion, or fluid overload, in patients with heart failure. FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.
scPharmaceuticals is a clinical-stage pharmaceutical company focused on developing and commercializing products that reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, products for 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 scPharmaceuticals.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the planned resubmission of the FUROSCIX NDA, including potential timing of the resubmission, the advancement of the Company’s human factors and device verification and validation studies. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the ability of the FUROSCIX Infusor to appropriately deliver therapy, the receipt of regulatory approval for FUROSCIX Infusor or any of our other product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, and the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K on file with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
Katherine Taudvin, scPharmaceuticals Inc.
Christopher F. Brinzey, Westwicke, an ICR Company