Acceleration of inhaled oxytocin to reduce maternal mortality

A novel form of oxytocin — an inhalable dry powder that does not require refrigeration — is in accelerated development at Monash Institute of Pharmaceutical Sciences (MIPS) to address the world’s leading cause of maternal mortality.

Every year, an estimated 60,000 women in resource-limited countries die due to postpartum haemorrhage (PPH), a condition of excessive blood loss after birth. It is hoped that inhaled oxytocin could enable ease of use by frontline health workers, birth attendants and mothers themselves.

MIPS is advancing the clinical development of inhaled oxytocin following a research and development agreement with Janssen Pharmaceutica NV — part of the Janssen Pharmaceutical Companies of Johnson & Johnson. The 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.

MIPS project lead Professor Michelle McIntosh said, “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,” Professor McIntosh added.

The Victorian Medical Research Acceleration Fund has announced it will co-fund a critical clinical trial to confirm the safety and performance of the optimised inhaled oxytocin product, which will also help to propel the project forward. 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,” Professor McIntosh explained.

The team at MIPS will also continue to collaborate with longstanding project partner GSK, which will continue to provide access to relevant technical expertise as required to support the ongoing development of inhaled oxytocin.

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