New target product profiles for prevention and treatment of preterm birth

The 2 target product profiles discussed in this survey have been formulated to meet the need for novel medicines for the prevention and management of preterm birth. Spontaneous preterm labour accounts for up to 50% of preterm births. Preterm birth is the leading cause of neonatal mortality, accounting for 35% of neonatal deaths globally. Preterm newborns that survive are at an increased risk of a number of short-term and long-term adverse health outcomes, including chronic lung disease, and neurological, visual and auditory disabilities.

There are currently very few effective medicines for preventing preterm birth in women at risk. Some tocolytic agents are available that can prolong pregnancy for 2 to 7 days in women experiencing spontaneous preterm labour, but there's a lack of evidence that current treatments improve substantive fetal and neonatal health outcomes. There's an urgent need for new tocolytics that can prolong pregnancy and reduce the adverse perinatal outcomes associated with preterm birth.

This page contains draft documents of 2 TPPs:

• TPP for the prevention of preterm birth
• TPP for the treatment of preterm labour

These documents are open for public consultation. If you wish to submit a response, please email tpp@burnet.edu.au

All the comments you provide will be treated as non-identifiable, which means that we will not attribute these comments to you by name, nor will anything that could identify you be released outside of our study team.