A Ceftriaxone Rectal Dosage Product to Prevent Neonatal Sepsis Deaths

Chancellor Masters & Scholars of the University of Oxford
Organization Location: 
Oxford, United Kingdom

Neonatal sepsis is a leading cause of preventable neonatal mortality. Ceftriaxone, listed by the WHO as an essential medicine, is one of three antibiotics recommended for treatment. It is only available as an injection, limiting use to hospitals, to which access is often difficult or impossible. In high mortality countries, about 60% of families refuse referral to hospital for young infants with critical illness. 

Rectal administration is a simple, safe and acceptable method of treating very sick children and would be suitable for community-based management of neonatal sepsis. With prior Saving Lives at Birth (SL@B) funding, this University of Oxford team has developed four low-cost, stable, early laboratory prototype formulations of ceftriaxone for rectal treatment of critically ill neonates to increase and simplify early treatment in high burden countries. Their animal bioavailability data on these formulations demonstrates therapeutic drug concentrations are reached quickly and sustainably over 24 hours. These results are extremely promising, requiring scale-up and refining of the manufacturing process and further stability studies prior to validation in man. Human clinical testing necessitates that a clinical batch of the prototypes are manufactured to Good Manufacturing Practice (GMP) standards by a pharmaceutical company.    
This project seeks funding to subsidize commercial pharmaceutical development in order to accelerate progress and reduce price. Proof of adequate bioavailability provides a solid basis for dialogue with regulatory authorities, development of a regulatory plan, Phase II and III trials in the target population, development and submission of a regulatory file for licensing and marketing.