Study: Heat-stable drug formulation offers new option to prevent postpartum bleeding

Data from a collaboration between Ferring Pharmaceuticals, Merck (NYSE:MRK) and the World Health Organization showed that a heat-stable formulation of carbetocin is as effective as oxytocin for the prevention of excessive bleeding following vaginal birth.

Millions of women are affected by postpartum hemorrhage every year, according to Ferring Pharmaceuticals. Traditionally, women are given oxytocin to prevent the deadly condition. But oxytocin has to be stored and transported at 2 – 8°C, which is not always possible in countries where adequate storage and distribution resources are scarce.

To address this problem, scientists at Ferring Pharmaceuticals developed a heat-stable formulation of carbetocin that can maintain its efficacy for at least three years at 30°C or six months at 40°C.

The Champion trial, which set out to compare the heat-stable formulation of carbetocin against oxytocin, included nearly 30,000 women in ten countries, according to Ferring Pharmaceuticals. The WHO, Ferring Pharmaceuticals and MSD for Mothers published the results of the trial in the New England Journal of Medicine.

Results showed that carbetocin is clinically non-inferior to oxytocin for the primary outcome of greater than 500 mL of blood loss or use of additional uterotonic, the pharma company touted.

“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,” Klaus Dugi, CMO at Ferring Pharmaceuticals, said in prepared remarks.”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.”

“No woman should die giving life, and our mission is to give mothers around the world access to affordable, life-saving medical interventions,” Julie Gerberding, Merck’s chief patient officer, said in a press release. “Prevention is key, which is why we are collaborating on the Champion project. The collaboration has brought innovation developed in the private sector into the public sector in an effort to address unmet needs in countries where the majority of maternal deaths occur.”

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