Pabal (carbetocin) new formulation approved through EU Mutual Recognition Procedure for prevention of uterine atony and postpartum haemorrhage - Ferring

Ferring announced that its new room-temperature-stable formulation of Pabal (carbetocin) for intravenous (IV) administration has been approved through the EU Mutual Recognition Procedure. Pabal is a long-acting synthetic analogue of human oxytocin with a half-life of approximately 40 minutes and is indicated for the prevention of uterine atony following delivery of the infant by caesarean section under epidural or spinal anaesthesia. The new formulation of Pabal is the first long-acting, room-temperature-stable oxytocic agent to be approved for this condition.

Room-temperature-stable Pabal is expected to become available in Europe during the second quarter of 2015. Uterine atony, or lack of muscle tone in the uterus, is responsible for approximately 80% of postpartum haemorrhage (PPH) cases. PPH is defined as a bleed of 500 mL or more in vaginal deliveries and in excess of 1000 mL in abdominal deliveries. International and national guidelines agree that active management of the third stage of labour is a key factor in preventing PPH. This is often achieved with uterotonic agents like oxytocin, ergometrine, syntometrine and the other formulations of carbetocin, all of which require refrigeration from manufacture, through distribution, storage and eventual use.