Insud Pharma has announced a collaboration with the Bill & Melinda Gates Foundation, receiving a $2.7 million grant to conduct a Phase II clinical trial for a sublingual oxytocin formulation aimed at preventing postpartum hemorrhage (PPH). PPH, defined by the World Health Organization (WHO) as the loss of more than 500 ml of blood within 24 hours of delivery, remains a leading cause of maternal mortality worldwide, particularly in low- and middle-income countries.
The sublingual oxytocin formulation, presented in a thermostable tablet form, offers a significant advantage as it does not require refrigeration and can be administered without skilled healthcare personnel. This characteristic makes it particularly suitable for regions with limited access to medical facilities and resources.
Clinical Trial Details
The Phase II clinical trial is scheduled to commence in the first quarter of 2025 and will involve 180 participants. The primary objective is to determine the optimal dose of sublingual oxytocin for PPH prevention. Secondary endpoints will likely include assessments of efficacy, safety, and ease of administration in resource-limited settings.
Addressing a Critical Need
According to the WHO, approximately 14 million women are affected by PPH each year, resulting in around 70,000 deaths. The majority of these deaths occur in Sub-Saharan Africa and South Asia, highlighting the urgent need for accessible and effective interventions. The development of a thermostable, sublingual oxytocin formulation could significantly reduce these numbers by providing a practical solution for managing postpartum emergencies.
Expert Commentary
Dr. Clara Menéndez, director of the Maternal, Infant and Reproductive Health Program at the Barcelona Institute for Global Health, emphasized the importance of this clinical trial, stating that "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.”
Insud Pharma's Commitment
Insud Pharma, specializing in women’s health through its brand Exeltis, has a long-standing commitment to developing accessible medicines. In collaboration with the Mundo Sano Foundation, Insud Pharma aims to launch awareness campaigns and facilitate access to the sublingual oxytocin treatment in underserved regions, ensuring that women in these areas benefit from this innovative solution.
