Ferring’s heat-stable carbetocin can prevent excessive bleeding after childbirth

Results from the largest study conducted in prevention of PPH with nearly 30,000 women, conducted by the WHO, were published in the New England Journal of Medicine

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.² Although most deaths are preventable,³ PPH is the leading direct cause of maternal death worldwide,⁴ 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,⁵ addressing a significant limitation of oxytocin which must be stored and transported at 2 – 8°C.^6,7 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.^7,8 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 per cent 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.

References
1. Widmer M, et al. Heat stable carbetocin vs oxytocin to prevent hemorrhage after vaginal birth. New England Journal of Medicine 2018;in press.

2. World Health Organization. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_16PPH.pdf Last accessed: May 2018.

3. World Health Organization. WHO recommendations for the prevention and treatment of postpartum haemorrhage. Published 2012. Available at: http://apps.who.int/irisbitstream/10665/75411/1/9789241548502_eng.pdf Last accessed: May 2018.

4. Say L, et al. Global causes of maternal death: a WHO systematic analysis. The Lancet Global Health. 2014; 2(6):e323-33. Available at: https://www.thelancet.com/pdfs/journals/langlo/PIIS2214-109X(14)70227-X.pdf Last accessed: May 2018.

5. Malm M, et al. Development and stability of a heat-stable formulation of carbetocin for the prevention of postpartum haemorrhage for use in low and middle-income countries. Journal of Peptide Science 2018;e3082.

6. Widmer M, et al. Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial. Trials 2016;17(1):143.

7. Torloni MR, et al. Quality of Oxytocin Available in Low and Middle-Income Countries: A Systematic Review of the Literature (Systematic Review on Quality of Oxytocin). An International Journal of Obstetrics and Gynaecology 2016;123(13):2076-2086.

8. Anyakora, et al. Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits. BMC Pregnancy and Childbirth 2018;18:44.