New Alliance for the Development of a Sublingual Oxytocin Formulation to Prevent Postpartum Hemorrhage

November 21, 2024 |

6 min read

Clinical Trial Results Could Help Save the Lives of Over 70,000 Pregnant Women Globally Each Year

According to the World Health Organization (WHO), puerperal or postpartum hemorrhage - PPH - is one of the leading causes of maternal mortality in the world
The Spanish laboratory Insud Pharma will receive funding from the Bill & Melinda Gates Foundation to conduct a Phase II clinical trial to determine the optimal dose of sublingual oxytocin to prevent PPH
The group, which specializes in women’s health, thus reinforces its commitment in this area in which it has been working for decades
The Mundo Sano Foundation will contribute to raising awareness of this clinical condition, and will 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

MADRID, Nov. 21, 2024 /PRNewswire/ -- Insud Pharma has just announced they will receive funding from the Bill & Melinda Gates Foundation, which includes a grant totaling $2.7 million, for the launch of a Phase II Clinical Trial to determine the optimal dose of an innovative sublingual oxytocin treatment designed to prevent postpartum hemorrhage.

This problem, characterized by excessive bleeding after childbirth, is one of the leading causes of maternal mortality worldwide, according to the World Health Organization (WHO). Currently, it is estimated to affect approximately 14 million women each year and causes around 70,000 deaths, mostly in low- and middle-income countries. With the implementation of this sublingual treatment, many lives could be saved and provide a practical and accessible solution for the management of postpartum emergencies.

This sublingual oxytocin formulation in tablet form has the characteristic of being thermostable, which means that it does not require refrigeration and could be administered without the need for skilled health personnel. This makes it particularly suitable for use in countries where access to rapid and safe medical care is very limited, as well as among the most disadvantaged communities, regardless of their geographic location*.

Funding provided by the Bill & Melinda Gates Foundation to Insud Pharma underscores the shared commitment of both organizations to advance maternal and child health globally. According to WHO, a woman dies every two minutes from causes related to pregnancy or childbirth, underscoring the urgency of reducing these deaths and meeting the Sustainable Development Goals.

Ensuring access

Insud Pharma, a leader in women’s healthcare, has been focused for decades on the research and development of accessible medicines to improve the quality of life for women at all stages of their lives.

Its commitment to innovation aims not only to save lives, but also to promote equality in global health in collaboration with Mundo Sano, the family foundation led by its shareholders, which has been working for 30 years to improve access to health for people affected by socially or economically determined diseases, promoting equity in health. Therefore, Insud Pharma, with their help, will launch innovative campaigns to address postpartum hemorrhage with the aim of also raising awareness and facilitating access to medication in the most underserved regions.

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, highlighted the importance and potential impact of this study, as well as the fundamental role of the industry in promoting it. Menéndez pointed out 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”.

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.

Ensuring that women have a safe delivery through PPH prevention, with access to quality healthcare and effective drugs - such as oxytocin - is critical to reducing maternal and infant mortality and improving the development of any community and country.

The clinical trial is expected to begin in the first quarter of 2025 and will include a total of 180 participants.

About Insud Pharma

Insud Pharma is a pharmaceutical group with more than 45 years of history, presence in around 50 countries, 9,000 employees worldwide and 20 manufacturing facilities. Insud Pharma operates along the entire value chain of the pharmaceutical industry, offering expertise in scientific research, development, manufacturing, sales and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceuticals for human and animal care, as well as biopharmaceuticals. Insud Pharma seeks to improve health worldwide by providing accessible, effective, safe and quality drug treatments through its different business units, with continuous investment in R&D and the latest technology. Through its brand Exeltis, Insud Pharma specializes in Women’s Health where it occupies a leading position accompanying women in all phases of life from preconception, pregnancy, postpartum or menopause.

About Mundo Sano

Mundo Sano Foundation is a family foundation created in 1993 with the purpose of improving access to health for people affected by socially or economically determined diseases, promoting equity in health. Through translational research, it generates a comprehensive approach that seeks to improve access to health for the most vulnerable populations; promotes research and the development of innovative tools for global programs for neglected diseases; contributes to the prevention of the transmission of these diseases; raises awareness in local communities about the importance of taking care of their health; and promotes the training of health professionals to contribute to the promotion of knowledge. It has cooperation agreements with entities such as the World Health Organization (WHO), Pan American Health Organization (PAHO), Barcelona Institute for Global Health (ISGlobal), Drugs for Neglected Diseases Initiative (DNDi), Harvard University -through the David Rockefeller Center for Latin American Studies-, Uniting to combat NTDs (Neglected Tropical Diseases) and the Global Chagas Coalition, among others.

Background information

According to WHO, puerperal hemorrhage, defined as the loss of more than 500 ml of blood within 24 hours of delivery, is the leading cause of maternal mortality worldwide.

It is estimated that a woman dies every two minutes from causes related to pregnancy or childbirth.

WHO publishes global plan to combat leading cause of death in childbirth

According to WHO, there are marked differences in survival rates following postpartum hemorrhage, reflecting great inequalities in access to essential health services. In this regard, more than 85% of deaths from postpartum hemorrhage occur in Sub-Saharan Africa and South Asia.

*Even in high-income countries such as the United States, maternal mortality rates are rising.

Stalled global progress on preventable maternal deaths needs renewed focus and action

Bill & Melinda Gates Foundation report on maternal mortality.

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