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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