The study aims to demonstrate that antimicrobial coverage following subcutaneous administration of ceftriaxone is fully comparable to antimicrobial coverage following standard intravenous administration. Antimicrobial coverage refers to time over the Minimum Inhibiting Concentration (MIC), a generally accepted measure of the adequacy of plasma levels of an antibiotic for treatment of infections with susceptible bacteria.
This study is part of scPharmaceuticals’ development program for a drug-device combination comprising ceftriaxone and the sc2Wear Ceftriaxone Patch Pump, a proprietary patch pump for subcutaneous administration of ceftriaxone. The sc2Wear Patch Pump is designed to enable convenient and comfortable controlled subcutaneous administration of injectable pharmaceuticals without the resources and costs of intravenous or intramuscular administration. scPharmaceuticals anticipates submitting a 505(b)(2) NDA in the second half of 2016 for the sc2Wear Ceftriaxone drug-device combination.
The sc2Wear Ceftriaxone Combination Product is scPharmaceuticals’ first antibiotic pipeline product entering the final stage of development. The product is intended to reduce risks and costs associated with antibiotic courses that require daily intravenous administration by means of a peripherally inserted central catheter (PICC). A PICC, also called a PIC line, is the standard method to administer ceftriaxone and other injectable antibiotics when a course of longer duration, typically seven days or more, is indicated.
Ceftriaxone was first introduced in 1984 and, as a result of its antibiotic efficacy and its convenient once-a-day administration, it became one of the most widely used injectable antibiotics. In the United States alone, approximately 30 million doses of ceftriaxone are administered annually. The most common indications for ceftriaxone use are lower respiratory tract infections (pneumonia), skin infections, and bone and joint infections.
The study is conducted in the US under the company’s investigational new drug (IND) application. The pivotal clinical study is part of a development program for which the company sought and received input from the FDA through in-person meetings and correspondence.
In the three-way cross-over study, standard intravenous administration of 1 gram of ceftriaxone over 30 minutes is compared to subcutaneous administration of 1 and 2 grams administered over 2 hours.
“The paradox of outpatient injectable antibiotic therapy is that we have a range of safe and effective antibiotics, but daily intravenous administration is associated with significant risks, discomfort, organizational burden, and high cost, said Ralph Corey, M.D., Professor of Medicine and Infectious Disease, Duke Clinical Research Institute and Duke University Medical Center. “Subcutaneous administration by means of a minipump holds a lot of promise, not only for ceftriaxone, but for a broad range of antibiotics.”
“Ceftriaxone has been one of the important pillars of antibiotic therapy for decades”, said Pieter Muntendam, MD, President and CEO of scPharmaceuticals. “The introduction of controlled subcutaneous administration of ceftriaxone may prove to be one of the transformative moments for outpatient antibiotic therapy by providing safer and more convenient care for less.”
Ceftriaxone (INN) is an antibiotic useful for the treatment of a number of bacterial infections. Ceftriaxone was introduced by Hoffmann-La Roche in 1984 under the trade name Rocephin. Ceftriaxone belongs to the cephalosporin group of antibiotics and is classified as a third-generation cephalosporin. Ceftriaxone cannot be taken by mouth and it is currently approved for administration by intravenous infusion or intramuscular injection.
Ceftriaxone is approved to treat the following infections when caused by susceptible bacteria: lower respiratory tract infections, ear infections, skin infections, urinary tract infections, gonorrhea, pelvic inflammatory disease, septicemia, bone and joint infections, intra-abdominal infections, and meningitis. It is also used preoperatively to reduce the risk of postoperative infections.
The sc2Wear Ceftriaxone Combination Product is subject to FDA and other regulatory review and approval prior to commercial introduction and clinical use.
scPharmaceuticals, Inc., based in Lexington, MA, is a privately held biopharmaceutical company developing a portfolio of transformative pharmaceutical products for subcutaneous delivery. Our innovative products are based on widely used generic drugs that currently require intravenous or intramuscular injections. They will be administered subcutaneously via the sc2Wear 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 parenteral antibiotic most widely 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 inpatient 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 costs. The company recently announced positive results from the pivotal trial of it novel subcutaneous furosemide formulation (November 4, 2015). For further information on how we are transforming the administration of parenteral drugs, go to www.scpharmaceuticals.com.