Ferring Pharmaceuticals receives EU approval for Misodel

Ferring Pharmaceuticals has announced that its removable misoprostol vaginal delivery system Misodel has received European regulatory approval.

The controlled-release system has been ratified for labour induction, having successfully completed the European Decentralised Procedure, involving 29 member states of the European Economic Area.

Each state will now adopt the decision and grant national marketing authorisations, a process that will take place over the next few months, allowing Ferring to commence the rollout of the product next year.

Misodel – which will be known as Mysodelle in some countries – will be used to induce labour in women with an unfavourable cervix from 36 weeks of gestation, in cases where induction is clinically indicated.

Positive phase III data on the vaginal insert was shared at the European Congress on Intrapartum Care earlier this year.

Dr Pascal Danglas, executive vice-president for clinical and product development at Ferring Pharmaceuticals, said: "We look forward to making this new product available to obstetricians and the growing number of patients for whom labour induction is clinically indicated."