Postpartum haemorrhage (PPH), a condition of excessive blood loss after birth, is the world's leading cause of maternal mortality, resulting in an estimated 60,000 deaths per year in resource-limited countries. A novel form of oxytocin, an inhalable dry powder that does not require refrigeration, could enable ease of use by frontline health workers, birth attendants and mothers themselves.
Monash University's Institute of Pharmaceutical Sciences (MIPS) has entered into a research and development agreement with Janssen Pharmaceutica N.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, to further advance the clinical development of inhaled oxytocin for the prevention of PPH in developing countries.
The research and development agreement builds on previous funding support from Janssen and will enable the specialist team at MIPS to rapidly evaluate their innovative dry powder formulation of oxytocin in preparation for large-scale, international trials.
The project lead at MIPS, Professor Michelle McIntosh says: "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."
"As we find ourselves in the clutches of a global pandemic, it's been encouraging to see many positive instances of the private sector working together with academia to provide solutions to industry identified problems. This collaboration is yet another great example of the pharmaceutical industry supporting and collaborating with academia to tackle a critical unmet medical need," added Prof. McIntosh.
The Victorian Medical Research Acceleration Fund will also help to propel the project forward as they announced that they will co-fund a critical clinical trial to confirm the safety and performance of the optimised inhaled oxytocin product. Successful completion of this trial will lead to a large-scale phase three efficacy study to be conducted across international sites, including Australia and low-income countries of high need.
Most deaths resulting from PPH could be avoided. In developed countries it's effectively managed using the gold standard therapy, oxytocin, a manufactured form of a natural hormone. However, access to quality oxytocin in low income countries is limited as 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 presents an innovative, low cost, heat stable and non-invasive approach to deliver oxytocin, overcoming existing limitations of current injection products.
"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.
The team at MIPS will also continue to collaborate with long-standing project partner, GSK. Following on from the agreement between MIPS and GSK which commenced in 2014, and aligned with its approach to identify and leverage different types expertise and partnerships to accelerate global health impact, GSK will continue to provide access to relevant technical expertise as required to support the ongoing development of inhaled oxytocin.
