"Efforts by Monash University to develop a heat stable, dry oxytocin delivery system through inhalation…could save the lives of almost 20,000 pregnant women each year" 1
A specialist team at Monash Institute of Pharmaceutical Sciences, led by Professor Michelle McIntosh, has developed an innovative, heat stable powder formulation of oxytocin that when inhaled, aims to provide the same protection against PPH as an intramuscular (IM) injection, the current global standard (ref).
Following demonstration of initial proofs of concept at Monash, a partnership with GSK (2014-2019) delivered significant progress to optimise this formulation and initiate the clinical development program:
- Our lead prototype product used in the early stage clinical trials has an approved 36 month shelf-life outside of the refrigerator
- Inhalation toxicology studies are complete and demonstrate that the powder is well-tolerated when administered to the lungs.
- A phase I, first-in-human clinical trial conducted in female, non-pregnant volunteers confirms that the blood profile (pharmacokinetics) of inhaled oxytocin is essentially similar to oxytocin administered using an intramuscular (IM) injection (see data below).
- A phase II study evaluating the product in our target population of women during the third stage of labour is complete and results will be published in 2020.
Safety, Tolerability and Pharmacokinetics of Single Doses of Oxytocin Administered via an Inhaled Route in Healthy Females: Randomized, Single-blind, Phase 1 Study. Fernando, Disala et al., EBioMedicine, Volume 22, 249 - 255, DOI: 10.1016/j.ebiom.2017.07.020
In 2019, Monash further enhanced the collaboration to deliver an affordable inhaled oxytocin product, through an R&D agreement with Janssen Pharmaceutica N.V. (a part of the Janssen Pharmaceutical Companies of Johnson & Johnson). This agreement will support the next stage phase 1 clinical trials and provides Janssen an option to take the technology through late stage development to commercialisation. GSK remains a project partner providing critical technical expertise and support. We greatly appreciate two large multinational pharmaceutical companies coming together to address an intractable global health issue in this way and hope this can serve as an exemplar in the field.
- Saving Lives, Protecting Futures: Progress Report on the Global Strategy for Women and Children’s Health. UN Every Woman, Every Child 2015