Insud Pharma has been granted $2.7 million in funding from the Bill & Melinda Gates Foundation to support a Phase II clinical trial of a novel sublingual oxytocin treatment aimed at preventing postpartum hemorrhage (PPH). The trial is scheduled to begin in the first quarter of 2025.
PPH is a leading cause of maternal mortality worldwide, affecting approximately 14 million women annually and causing around 70,000 deaths, according to the World Health Organization (WHO). The majority of these deaths occur in low- and middle-income countries. Current statistics indicate that a woman dies every two minutes from pregnancy or childbirth-related causes, with over 85% of postpartum hemorrhage deaths occurring in Sub-Saharan Africa and South Asia.
Sublingual Oxytocin: A Novel Approach
The innovative treatment is a thermostable tablet form of oxytocin that does not require refrigeration or skilled healthcare personnel for administration. This makes it particularly valuable for regions with limited access to medical care. The Phase II clinical trial will include 180 participants to determine the optimal dose for the sublingual oxytocin treatment.
Expert Commentary
Dr. Clara Menéndez, director of the Maternal, Infant and Reproductive Health Program at the Barcelona Institute for Global Health, emphasized the equity implications of this development: “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.”
Menéndez added that, “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.”
Mundo Sano Foundation, Insud Pharma’s family foundation, will support awareness campaigns and facilitate access to the medication in underserved regions.
