Ferring Pharmaceuticals announced new data demonstrating that its heat-stable formulation of carbetocin is as effective as the current standard of care, oxytocin, for the prevention of excessive bleeding, also known as postpartum haemorrhage (PPH), after vaginal birth.1
Results from the CHAMPION clinical trial, conducted by the World Health Organization (WHO) as part of a collaboration with Ferring and MSD for Mothers**, were published in the New England Journal of Medicine (NEJM).1 This is the largest study conducted in the prevention of PPH with nearly 30,000 women in ten countries.1
Every year, 14 million women are affected by PPH.[ii] Although most deaths are preventable,[iii] PPH is the leading direct cause of maternal death worldwide,[iv]causing approximately 70,000 deaths per year.4
“This is an important step forwards in PPH prevention and these results pave the way for heat-stable carbetocin to potentially save the lives of thousands of women, especially in areas where cold-chain transport and storage is not feasible,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “We will now work with the WHO and MSD for Mothers to make heat-stable carbetocin available in countries where it is needed most, protecting women and families around the world.”
Researched and developed by Ferring as a solution to address unmet needs in women’s health, heat-stable carbetocin remains effective at high temperatures,[v]addressing a significant limitation of oxytocin which must be stored and transported at 2 – 8°C.[vi],[vii] Studies in low- and lower-middle income countries have revealed degradation and loss of efficacy in oxytocin ampoules, which could be due to inadequate storage and distribution conditions.7,[viii] Data show that heat-stable carbetocin maintains effectiveness for at least three years at 30°C and six months at 40°C.5 Heat-stable carbetocin has the potential to save thousands of women’s lives in low- and lower-middle income countries, where 99% of PPH-related deaths occur2 and where the refrigeration of medicines can be difficult to achieve and maintain.6
The CHAMPION trial was conducted by the WHO Department of Reproductive Health and Research including the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), using Ferring’s heat-stable carbetocin, and funded by MSD for Mothers.1,6 Ferring will now seek registrations and manufacture heat-stable carbetocin. The parties will work together with the aim of making heat-stable carbetocin available at an affordable and sustainable price in the public sector of low- and lower-middle income countries that have a high burden of maternal mortality.
* The availability of heat-stable carbetocin is subject to regulatory review and approval in relevant countries.
** Known as Merck & Co., Inc., Kenilworth, N.J., U.S.A.