A US$1 million grant will ensure a life-saving drug formulation, that could prevent thousands of women from the fatal loss of blood after giving birth, will be ready for human trials in 2013.
Under new funding through the Bill & Melinda Gates Foundation’s Grand Challenges Explorations (GCE) initiative, Monash University researchers will engineer a drug that could save the lives of up to 150,000 women in developing countries who die each year at childbirth from postpartum haemorrhage, an uncontrolled loss of blood after delivery of a baby.
Led by Dr Michelle McIntosh, researchers from the Monash Institute of Pharmaceutical Sciences (MIPS) and the Faculty of Medicine, Nursing and Health Sciences will further test the stability and efficacy of a dry powder formulation of oxytocin in an aerosol inhalant format, identify a suitable inexpensive inhaler device, and prepare for clinical trials.
Oxytocin is widely used in the treatment of postpartum haemorrhage and currently can be administered via injection only by a trained healthcare professional and the vials must be kept refrigerated. This poses a major barrier for women in developing countries, where refrigeration is limited and more than 50 per cent of women give birth at home.
Dr Michelle McIntosh said developing oxytocin for aerosol delivery would remove the need for refrigerated storage and allowed patients to inhale the drug immediately after childbirth, resolving existing barriers to treatment in developing countries.
“Every minute a mother will die from pregnancy and childbirth associated complications, and many of these deaths will occur within 1-2 hours of giving birth due to severe postpartum haemorrhage,” Dr McIntosh said.
“The real tragedy of this statistic is that it is almost completely preventable. The drug exists, it’s safe, it’s effective, and we know it can save lives. The inhaled form of oxytocin that we are developing is a needle-free and non-refrigerated option suitable for use in remote areas with limited training.
“We know that children in developing countries without a mother are more likely to die before the age of five so we’re really hoping this product will benefit, not just women but their families and the broader community.”
The project’s phase I research proved that the inhalation of pharmaceutically engineered particles of oxytocin could rapidly induce therapeutically-relevant contraction of uterine smooth muscle, therefore preventing and treating postpartum bleeding.
Dr McIntosh and the team will continue to improve the stability of the oxytocin powder and further characterise the relationship between oxytocin delivered to the lungs and effectiveness in a preclinical model.
Director of MIPS and Dean of the Faculty of Pharmacy and Pharmaceutical Sciences at Monash, Professor Bill Charman, said the University was well positioned to deliver the drug alternative that could transform the lives of those most in need.
“We’re uniquely placed to bring together the technology skill sets, people with a passion to drive the program, and to make the linkages both within the institute and our broader partner network that enable this medicine to be developed as rapidly as possible,” Professor Charman said.
The Inhaled Oxytocin Project was the only Australian research project to receive phase II funding in the latest Explorations grants funding round announced by the Bill & Melinda Gates Foundation.