The study titled “Pharmacokinetic Response after Subcutaneous Administration of Ceftriaxone” was presented on Saturday October 29th. The primary end-point for the study was non-inferior antimicrobial coverage when compared to the same dose given by intravenous infusion. Antimicrobial coverage refers to time over the Minimum Inhibitory Concentration (MIC), a generally accepted measure of the adequacy of plasma levels of an antibiotic for treatment of infections due to susceptible bacteria.
“This represents an important milestone in our quest to make widely-used antibiotics available without the risks, discomfort and costs associated with infusion lines that are routinely required for longer courses of antibiotic treatment.” said Pieter Muntendam, M.D., president and CEO of scPharmaceuticals. “These results indicate that antimicrobial coverage following subcutaneous administration of ceftriaxone is fully comparable to antimicrobial coverage following standard intravenous administration.”
The three-way, cross-over study compared one gram administered subcutaneously over two hours with one gram administered intravenously over 30 minutes and included a third treatment involving subcutaneous administration of two grams of ceftriaxone. The study was conducted in the US under the company’s Investigational New Drug (IND) application.
This pivotal study is part of scPharmaceuticals’ development program for a drug-device combination product comprising ceftriaxone and the sc2Wear Ceftriaxone Infusor, a proprietary patch-pump for subcutaneous administration. The sc2Wear Infusor is designed to enable convenient, subcutaneous self-administration of injectable pharmaceuticals, without the required resources and costs of intravenous and intramuscular administration. Ceftriaxone was first introduced in 1984 and, as a result of its antibiotic efficacy and its convenient once-a-day administration, became one of the most widely used injectable antibiotics.
The sc2Wear Ceftriaxone Combination Product is subject to FDA and other regulatory review and approval prior to commercial introduction and clinical use.
scPharmaceuticals, based in Lexington, MA, is a privately held biopharmaceutical company developing a portfolio of transformative pharmaceutical products for subcutaneous delivery. Based on widely used generic drugs that currently require intravenous or intramuscular injections, innovative products will be administered subcutaneously via a proprietary patch pump. This avoids material risks and costs associated with the current delivery options. Our lead products are the first subcutaneous formulation of furosemide (the most widely used parenteral diuretic in treating heart failure), and ceftriaxone (the most widely used parenteral antibiotic used outside the hospital setting). Our novel furosemide formulation enables convenient anytime anywhere use, for example in an outpatient setting instead of the emergency room or other in-patient settings. For ceftriaxone and other antibiotics, subcutaneous administration eliminates the need for PICCs (peripherally inserted central catheters), which are associated with serious complications, frequent adverse events and high medical cost. For further information on how we are transforming the administration of parenteral drugs, go to www.scpharmaceuticals.com.