GSK announced the start of a phase 3 program to evaluate the efficacy and safety of retosiban, an investigational oxytocin antagonist. Retosiban is being developed as a potential treatment to improve neonatal outcomes of babies born to women in spontaneous preterm labor by prolonging the time to delivery.
A preterm (or premature) birth is when a baby is born at least three weeks before the expected due date. The earlier a baby is born, the more severe the baby’s health problems are likely to be. Some preterm babies require special care to stay alive and can spend months in hospital in a neonatal intensive care unit and some may suffer lifelong consequences.
The first study in the retosiban phase 3 program is designed to demonstrate the efficacy and safety of retosiban in women with spontaneous preterm labor when compared with atosiban, an oxytocin/vasopressin antagonist. The primary outcome measure of this study is the time to delivery after the start of treatment. The key secondary endpoints will measure neonatal morbidities and mortality. A follow-up study will assess the long-term safety and outcomes of the infants born to mothers participating in the retosiban treatment studies. Further studies are also planned.
Pauline Williams, Vice President and Head of GSK Maternal & Neonatal Health Unit said: “Preterm birth is a leading cause of illness and death in newborns and infants worldwide. As part of our efforts to address this issue, we are evaluating whether retosiban can potentially stop preterm labor and whether increasing the gestational age of a newborn baby can reduce the complications of prematurity.”
Retosiban is not approved or licensed for use anywhere in the world.
Source: Glaxosmithkline
Filed Under: Drug Discovery
