The pivotal clinical trial in the development program for subcutaneous (SC) ceftriaxone has met its targeted endpoints, scPharmaceuticals, Inc., has reported. The trial’s primary endpoint was noninferior antimicrobial coverage compared with that of the same dose given by intravenous (IV) infusion.
Antimicrobial coverage refers to the time over the minimum inhibitory concentration (MIC), a generally accepted measure of the adequacy of plasma levels of an antibiotic for the treatment of infections due to susceptible bacteria.
The three-way, cross-over study compared 1 g of SC ceftriaxone administered over two hours with 1 g of IV ceftriaxone administered over 30 minutes and included a third treatment involving SC administration of 2 g of ceftriaxone. The study was conducted in the U.S.
At the 12-hour time point, plasma levels after SC administration of ceftriaxone were approximately 30% higher than that observed after standard IV administration. This indicated that the antibacterial effect was at least equivalent to standard IV administration. The mean plasma concentrations at 12 hours were 37 mcg/mL for 1 g of SC ceftriaxone, 28 mcg/mL for 1 g of IV ceftriaxone, and 61 mcg/mL for 2 g of SC ceftriaxone.
This study was part of scPharmaceuticals’ development program for a drug–device combination product consisting of ceftriaxone and the sc2Wear ceftriaxone pump, a proprietary patch pump for SC administration of ceftriaxone.
Ceftriaxone was originally 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. The drug cannot be taken by mouth and is currently approved for administration by IV 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.
Source: scPharmaceuticals; March 2, 2016.