scPharmaceuticals Inc. provides Furoscix update on heart failure re-submission.
scPharmaceuticals Inc. provided an update on Furoscix and announced a new $20.0 million term loan with Solar Capital Ltd. and Silicon Valley Bank.
�We continue to make excellent progress advancing the Furoscix program in preparation for the resubmission of the new drug application (NDA),� said John Tucker, president and chief executive officer of scPharmaceuticals. �Having completed our initial drug stability work and being on schedule to start the second of two human factors studies, we feel comfortable reconfirming our timelines and expectations for a mid-year 2020 resubmission of the Furoscix NDA. Additionally, as we look forward towards our longer-term funding needs, we are pleased to announce the closing of a new $20.0 million term loan agreement. With a strong cash position already in place, the access to the additional capital from the new term loan further strengthens our financial flexibility as we approach key regulatory and commercial milestones.�
Furoscix Update :Furoscix is scPharmaceuticals� lead program for the treatment of congestion in patients with heart failure. The Company continues to execute on key milestones ahead of resubmission of the NDA, including drug stability testing, the advancement of its second human factors study, and increasing awareness of Furoscix within the medical community. The Company is reiterating prior guidance and remains confident it will resubmit the Furoscix NDA with the FDAby mid-year 2020.
Completed initial drug stability work. Drug stability testing is a required element of the Furoscix resubmission and a requirement of all drug products undergoing regulatory review. The Company has recently completed the requisite three primary batches of drug product. These batches will form the basis of the drug stability portion of the Furoscix resubmission. Company remains on track to initiate the second of two planned Furoscix human factors studies. Two human factors studies designed to assess and optimize user interaction with the Furocix Infusor interface are to be conducted under the current 505(b)(2) approval pathway for Furoscix. The Company announced the completion of the first study in August 2019. The Company has submitted and received feedback from the FDA on the human factors validation study and is on track to complete the second study by the end of the year. The second study will evaluate the usability of Furoscix by patients, caregivers, and healthcare providers.
Presentation at the 23rd Annual Heart Failure Society of America (HFSA) Scientific Meeting: A poster on the use of Furoscix in patients after hospitalization for acute decompensated heart failure was presented at the HFSA on September 14th, 2019, in Philadelphia, PA. �It is encouraging to see continued diuresis and decongestion with Furoscix in patients, post-hospital discharge, for an episode of acute decompensated heart failure. We look forward to continuing to evaluate the clinical and economic benefits of this novel approach,� said G. Michael Felker, MD, Principal Investigator of the Sub-Q Study titled, Subcutaneous furosemide in the treatment of patients after hospitalization with acute decompensated heart failure.
Related news and insights
Medtronic announced the United States launch of the Penditure left atrial appendage (LAA) exclusion system, an implantable clip preloaded on a single-use delivery system for LAA management during concomitant cardiac surgery procedures
GSK plc announced positive headline results from a planned interim efficacy analysis of the DREAMM-7 head-to-head phase III trial evaluating belantamab mafodotin as a second-line treatment for relapsed or refractory multiple myeloma