Developed from a mouthwash, an antiseptic gel for preventing umbilical cord infection in newborns gets a nod from a European agency, a step closer to being used by developing nations.
GlaxoSmithKline developed antiseptic chlorhexidine gel Umbipro with the charity group Save the Children to be sold at a not-for-profit price in developing countries. Based on UN estimates, the product targeting omphalitis or umbilical cord infections is expected to save about 422,000 lives.
The antiseptic gel was endorsed on April 29 by the European Medicines Agency’s Committee for Medicinal Products for Human Use, although it still needs to be approved by local regulators. According to GSK, it will apply to countries that post moderate to high neonatal death rates.
The brand reformulated the chlorhexidine solution in its Corsodyl mouthwash into the gel, whose formulation is deemed stable given high humidity and heat, does not need to be refrigerated, and can be easily distributed in remote places. The gel is packed in single-use foil sachets that can be opened without the use of scissors.
“[C]hlorhexidine, an antiseptic and disinfectant, is effective against a wide range of Gram-negative and Gram-positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses,” stated the committee opinion.
Umbilical cord infections are considered more prevalent in low-income areas across Africa and Asia, where there are more births at home typically using unsterile objects, such as dung ash, for the umbilical cord stump.
“[O]ur expertise of working with health workers and communities has meant that this product can be used in challenging contexts,” said Save the Children program director Ali Forder.
Patrick Vallance, pharmaceuticals research and development president of GSK, said this gel is proof of the importance of combining expertise in pharmaceuticals and consumer health, such as toothpastes and mouthwash.
The company is planning to initially produce about 6 million units of the gel, as well as share its manufacturing know-how with other firms looking to create the product.