Janssen Pharmaceutica N.V. and Monash University have entered into an R&D agreement to accelerate the clinical development of a novel medicine that can save the lives of women in childbirth.
The agreement builds on earlier funding support from Janssen. It will enable Monash University’s Institute of Pharmaceutical Sciences (MIPS) to rapidly evaluate its novel form of oxytocin – a powder formulation that does not require refrigeration and can be inhaled.
It is hoped this innovative formula can be used by frontline health workers, birth attendants and even mothers themselves to prevent postpartum haemorrhage (PPH), a condition where excessive blood is lost after birth. PPH is the world’s leading cause of maternal mortality. In resource-limited countries, it results in up to 60,000 deaths a year.
‘PPH is a significant and challenging global health issue so we’re very excited to be collaborating with Janssen to accelerate the development of this urgently needed healthcare innovation, which has been uniquely designed for affordability and simplicity of use in resource-constrained settings,’ says Professor Michelle McIntosh, the project lead at MIPS.
The Victorian Medical Research Acceleration Fund has also announced it will co-fund a clinical trial to confirm the safety and performance of the optimised inhaled oxytocin product. Once this trial is successfully completed, a large-scale phase three efficacy study will be conducted across Australia and low-income countries of high need.
In developed countries, PPH is managed using oxytocin, a manufactured form of a natural hormone. However, current products are only available in an injectable form requiring supply and storage under refrigerated conditions and trained personnel to administer the product safely. Inhaled oxytocin offers a low-cost, heat-stable and non-invasive approach to deliver oxytocin.
‘Making an oxytocin inhaler a standard part of every midwife’s bag, or including one in a safe birthing kit for expectant mothers, could be the difference between life and death for hundreds of thousands of women,’ says Professor McIntosh.
Read about Monash University’s inhaled oxytocin project.