ScPharmaceuticals Inc. said it received a letter from the U.S. Food and Drug Administration citing deficiencies in its application for heart failure treatment Furoscix Infusor.
The company's drug-device combination product uses a needle to infuse furosemide in the abdomen of heart failure patients suffering from excessive fluid retention.
Furosemide, in oral or intravenous form, is widely used to help heart failure patients discharge excess fluid through urination to prevent a successive heart failure. Furoscix Infusor is expected to help patients reduce hospitalization costs by administering furosemide in an outpatient setting.
ScPharmaceuticals said the regulator has identified deficiencies that would prevent any further discussion on labeling and postmarketing requirements. The FDA letter did not specify the deficiencies identified as part of the regulator's ongoing review.
The company, which went public in November 2017, said it intends to work with the FDA to understand the deficiencies and resolve them as soon as possible.
The FDA had set a decision date of June 23 regarding its review of the application for Furoscix Infusor.
Following the announcement, the company's shares were down 30.03% to $9.95 as of 3:53 p.m. ET on May 31.
