ScPharmaceuticals Sees Phase III Clinical Trial Success Of Subcutaneous Antibiotic and Pump
The clinical trial involved 18 participants who were using the combination device to receive doses of Roche’s common antibiotic, ceftriaxone.
March 7, 2016 | by Sarah Massey, M.Sc.
Massachusetts-based scPharmaceuticals reported promising Phase III clinical trial results for its sc2Wear Pump: a wearable device designed to administer subcutaneous antibiotics. The clinical trial involved 18 participants who were using the combination device to receive doses of Roche’s common antibiotic, ceftriaxone.
Ceftriaxone is currently administered via intravenous central catheters, however this drug delivery method presents a number of risks including infection, irregular heartbeat and deep vein thrombosis. ScPharmaceuticals reported that plasma levels of antibiotic were approximately 30 percent higher in patients using the sc2Wear Pump for their daily regimen, compared to those that received the drug via an intravenous central line.
The company plans to submit the clinical trial data to the US Food and Drug Administration (FDA), as part of a 505(b)(2) New Drug Application, to be submitted later this year. “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 ceftriaxone treatment,” said Dr. Pieter Muntendam, CEO of scPharmaceuticals. “These results indicate that antimicrobial coverage following subcutaneous administration of ceftriaxone is fully comparable to antimicrobial coverage following standard intravenous administration.”
ScPharmaceutical’s pump contains an activator – designed to control the pump – along with a cartridge meant for single-use only. The cartridge itself consists of a pump used for drug delivery, a mechanism to control needle function, a reservoir for the antibiotic fluid, and an adhesive back designed to adhere to the skin.
Sensile Medical was the designer of the micropiston pump which is capable of pumping fluid up or down to subcutaneously administer the drug from a standard container. Roche’s ceftriaxone – marketed under the trade name Rocephin – is used to treat a number of different bacterial infections, and is prescribed over 30 million times in the US each year.
The company is also developing an alternate use for the sc2Wear pump in delivering subcutaneous furosemide to treat fluid buildup in heart failure patients. ScPharmaceuticals plans to file for both US and EU regulatory approval for this product in late 2016.
Keywords: Clinical Trials, Antibiotic, Medical Device
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