ScPharmaceuticals Inc. said the U.S. Food and Drug Administration rejected its application to market Furoscix, a potential therapy for edema, or an abnormal accumulation of fluid in the body, in people with heart failure.
The Burlington, Mass.-based company received a complete response letter from the agency indicating that scPharmaceuticals needs to consider device modifications and conduct additional research, potentially including a validation study in people. The FDA had until June 23 to render a decision on the application, which was accepted for review in November.
ScPharmaceuticals, which went public in November, previously said the FDA had flagged deficiencies in its Furoscix application.
"Our team will continue to work closely with the FDA to determine an appropriate path forward regarding product performance, appropriate patient identification, and risk mitigation strategies that ultimately enable a timely resubmission" of the application, President and CEO John Tucker said in a June 13 statement.
ScPharmaceuticals develops products that enable patients to give medicines normally administered intravenously to themselves via subcutaneous injection, or just under the skin. Furoscix, the company's most advanced pipeline product, is a subcutaneous version of an older drug, furosemide, which is used as a diuretic to expel excess fluid from the body through urination.
The company's shares were down almost 23% to $5.88 a share as of 3:45 p.m. ET.