Innovations in the prevention and treatment of postpartum hemorrhage: Analysis of a novel medicines development pipeline database

Abstract

BackgroundA significant barrier to improving prevention and treatment of postpartum hemorrhage (PPH) is a lack of innovative medicines that meet the needs of women and providers, particularly those in low‐and middle‐income countries (LMICs). The Accelerating Innovation for Mothers (AIM) project established a new database of candidate medicines under development for five pregnancy‐related conditions between 2000 and 2021.ObjectiveTo systematically identify and rank candidates for prevention and treatment of PPH.Search StrategyAdis Insight, Pharmaprojects, WHO ICTRP, PubMed, and grant databases were searched to develop the AIM database.Selection CriteriaAIM database was searched for candidates being evaluated for PPH prevention and treatment, regardless of phase.Data Collection and AnalysisCandidates were ranked as high, medium, or low potential based on prespecified criteria. Analysis was primarily descriptive, describing candidates and development potential.Main ResultsOf the 444 unique candidates, only 39 pertained to PPH. One was high potential (heat‐stable/inhaled oxytocin) and three were medium potential (melatonin, vasopressin and dofetilide via nanoparticle delivery).ConclusionThe pipeline for new PPH medicines is concerningly limited, lacking diversity, and showing little evidence of novel technologies. Without significant investment in early‐phase research, it is unlikely that new products will emerge.

Analysis of a maternal health medicines pipeline database 2000–2021: New candidates for the prevention and treatment of fetal growth restriction

“…We have previously reported on the development of the AIM database 15 . Briefly, a total of 444 medicines (including drugs, biological therapies and dietary supplements) in various stages of development for five pregnancy‐related conditions (preterm labour/birth, pre‐eclampsia/eclampsia, fetal growth restriction, intrapartum fetal distress and postpartum haemorrhage) were collated into a single database.…”

“…We have previously reported on the development of the AIM database. 15 Briefly, a total of 444 medicines (including drugs, biological therapies and dietary supplements) in various stages of development for five pregnancy-related conditions (preterm labour/birth, pre-eclampsia/eclampsia, fetal growth restriction, intrapartum fetal distress and postpartum haemorrhage) were collated into a single database. This was achieved through the systematic searching of AdisInsight, Pharmaprojects, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), PubMed and other clinical trial and grant databases to identify relevant candidate medicines (Figure 1).…”

Systematic evaluation of the pre-eclampsia drugs, dietary supplements and biologicals pipeline using target product profiles

“…Development of the AIM database has been previously described [20,21]. Briefly, the database was populated by searching Adis Insight, Pharmaprojects, WHO international clinical trials registry platform (ICTRP), PubMed and grant databases to identify candidate medicines investigated for five priority maternal conditions (pre-eclampsia, preterm birth/labour, postpartum haemorrhage, foetal growth restriction and foetal distress).…”

The drug drought in maternal health: an ongoing predicament

“… 12 Despite this burden, there have not been any new medical innovations for these conditions that reflect the current knowledge of disease evolution and progression processes. In addition, we investigated the current market challenges and potential solutions for the development and introduction of medicines for pregnancy-specific conditions through literature reviews and stakeholder consultation, 13 and by developing target product profiles (a document describing the minimum and preferred, or optimal, characteristics of a target product, aimed at a particular disease) to better direct maternal health medicine R&D. 14 , 15 In this Health Policy, we present the methods and main findings of the AIM database of maternal health medicines and discuss the ongoing market failures that need to be addressed. Although our current research focuses on the five high-priority, pregnancy-specific conditions discussed above, we acknowledge the impact of a wide range of other pregnancy-specific conditions, which are also chronically under-represented in clinical research and funding.…”