$2.7m grant for Insud Pharma to tackle postpartum hemorrhage
Funding came from the Bill & Melinda Gates Foundation
Severe bleeding after childbirth - postpartum haemorrhage (PPH) is the leading cause of maternity mortality worldwide.
Insud Pharma, a Spanish pharma group, has announced it is to receive funding from the Bill & Melinda Gates Foundation - including grant funding of $2.7m - to continue its work developing sublingual oxytocin to prevent PPH and reduce maternal mortality.
Easy to administer tablet
PPH is characterised by excessive bleeding after childbirth. It is estimated to affect approximately 14 million women each year and causes around 70,000 deaths, mostly in low- and middle-income countries.
Currently, injectable oxytocin is recommended by the World Health Organisation (WHO) for PPH prevention and treatment. However, oxytocin injections require trained healthcare providers and proper storage conditions, which are not always available in low-resource settings.
Instead, Insud Pharma's sublingual oxytocin tablet is oxytocin in a tablet form which can be placed under the tongue. It doesn’t need to be refrigerated, is easy to administer without skilled personnel and is suitable for use in areas with limited access to medical care.
This innovation could potentially reduce maternal deaths from PPH, especially in low- and middle-income countries where access to traditional oxytocin administration methods is limited.
Preventing 70,000 deaths globally
Insud will use its grant funding for a Phase II clinical trial which aims to identify the optimal dose needed in the tablet. Insud estimates that its clinical trial results could help save the lives of over 70,000 pregnant women globally each year.
Insud will work with the Mundo Sano Foundation - the family foundation led by its shareholders - who will raise awareness of the clinical condition, facilitate the dissemination of the results of the clinical trial as well as access to sublingual oxytocin in the geographical areas with the highest maternal mortality rates.
Dr Clara Menéndez director of the Maternal, Infant and Reproductive Health Program at the Barcelona Institute for Global Health, and advisor on this subject to the Mundo Sano Foundation, said:
"Access to effective drugs with the potential to save the lives of pregnant women is a question of equity, that all women, regardless of where they live, have the same right not to die in childbirth.
“despite its importance, clinical trials on conditions related to maternal health are still scarce. Therefore, this clinical trial is a milestone, especially as it is conducted in low-income countries, although its potential impact will be much broader.”
The clinical trial is expected to begin in the first quarter of 2025 and will include a total of 180 participants.