New medicine to prevent mothers dying in childbirth succeeds in first trial in humans
Advertisement
The Monash University Institute of Pharmaceutical Sciences (MIPS) today announced positive results from a first-in-human study of a new, inhaled form of a medicine that could significantly reduce maternal deaths around the world. 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.
This is an inhaler used to administer oxytocin.
Monash University
Every year, over 300,000 women in low and low-middle income countries die during pregnancy and childbirth. Postpartum haemorrhage (PPH) is the single largest cause of these deaths.
PPH can be prevented by administering a drug called 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, who sponsored the study, have been developing an inhalable, dry-powder form of oxytocin.
Today at the Royal College of Obstetricians and Gynaecologists World Congress in Cape Town, South Africa, the results of the first in-human trial of the new formulation were announced.
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 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 that it could reach the mothers who need it much sooner.
Associate Professor Michelle McIntosh, Project Leader at MIPS, said that this first in-human data offers hope to the many women in resource-constrained settings who do not currently have access to this essential medicine.
"These results show that oxytocin can be delivered similarly via inhalation or injection and therefore we are less likely to be required to conduct the extensive and costly trials needed for an entirely new drug. Instead, we should be able to move forward with trials on a much smaller scale, featuring patients numbering in the hundreds rather than tens of thousands, potentially making the medicine available much sooner," Associate Professor McIntosh said.
This positive data has supported the initiation of clinical studies evaluating inhaled oxytocin when given to women immediately after birth, the time at which oxytocin is routinely administered for prevention of PPH.
Other news from the department science
Most read news
More news from our other portals
Last viewed contents
Merck Signs Definitive Agreement to Acquire Life Science Company Mirus Bio for US$ 600 million - "This strategic acquisition is a further building block for accelerating growth in the break-through technologies of the future"
Thermo Fisher Scientific Forms Consortium to Drive Immunotherapy Research Across Europe
Risk of lead poisoning from urban gardening is low, new study finds
World first: Launch of Quebec registry for users of medical cannabis - MUHC researcher heads one of the largest studies ever conducted on medical cannabis
Implant-based cancer vaccine is first to eliminate tumors in mice - New approach reprograms the mammalian immune system to attack tumors body-wide
Study IDs link between sugar signaling and regulation of oil production in plants
It all adds up: Study finds forever chemicals are more toxic as mixtures - Research also finds that PFOA and PFOS are major contributors to toxicity
Affibody to publish data on therapeutic effects of Affibody molecules in a cancer model
‘Seaweed drug’ helps fight off infection - Alginates found in seaweed can combat multi-drug resistant infections
Antibiotic-releasing polymer may help eradicate joint implant infection
Unraveling the genome in 3D-space - Groundbreaking method to map contact points between replicated DNA molecules, thereby elucidating how the genome is folded inside the nucleus of human cells
