Inhaled oxytocin succeeds in first trial in humans
The first-in-human study of a new, inhaled form of oxytocin developed at MIPS has been successful. The results open the possibility of a streamlined pathway to registration, meaning that the medicine could be accessible to mothers much sooner than would otherwise be possible.
The study demonstrated, in a small cohort of non-pregnant female volunteers, that the effects that inhaled oxytocin has on the body are not meaningfully different from its injected counterpart. This gives confidence that the inhaled form of oxytocin will deliver similar effects in prevention of postpartum haemorrhage (PPH) when given to mothers immediately after giving birth.
The results present the possibility that the new medicine will be able to take advantage of a streamlined pathway to registration, meaning it could reach the mothers who need it much sooner.
Every year, more than 300,000 women in low and low-middle-income countries die during pregnancy and childbirth. PPH is the single-largest cause of these deaths.
PPH can be prevented by administering oxytocin, which is recommended by the World Health Organisation and is widely used in wealthy countries.
However, as an injection, oxytocin requires refrigeration and a skilled medical professional to administer it safely. In low and low-middle income countries, one or both of these requirements may not be available.
To address this unmet need, researchers at MIPS, in collaboration with GlaxoSmithKline in London, which sponsored the study, have been developing an inhalable, dry-powder form of the medicine.
The study was conducted and funded by GSK, with Monash support funded by the McCall MacBain Foundation, the Planet Wheeler Foundation and Grand Challenges Canada, and the government of Canada.