Ferring Pharmaceuticals, a research-driven, specialty biopharmaceutical group active in global markets, 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.

“Preventing uterine atony saves lives,” said Pascal Danglas, MD, executive vice president and chief medical officer at Ferring Pharmaceuticals. “By removing the necessity of refrigeration, Ferring aims to make Pabal more easily accessible. Expanding access to such medications is central to our commitment to women’s health globally.”

Based on the results obtained in stability studies, the new formulation has a recommended storage and shelf-life of 24 months at 30ºC and 75% humidity, which may be helpful in low-income countries where cold-chain storage and transport may not be available.

Ferring, MSD (known as Merck in the United States and Canada) and the World Health Organization (WHO) are working together with the aim of making the room-temperature-stable formulation of carbetocin for intramuscular administration available in the public sector of developing countries that have a high burden of maternal morbidity and mortality, at an affordable and sustainable price. As part of this collaboration, WHO will conduct a multi-country clinical trial to evaluate the effectiveness of this formulation (as compared to oxytocin) in preventing uterine atony in the third stage of labour in women who have delivered vaginally. The study will take place in 11 countries around the world and enrol approximately 30,000 women.

Since its introduction in 1999, Pabal has been approved for the prevention of uterine atony in over 70 countries. With a single 100mcg IV dose, it stimulates uterine contractility within two minutes, and sustains rhythmic contractions for one hour. It raises uterine tone and provides protection against uterine atony for up to 48 hours, thus reducing the risk of blood loss. In women undergoing caesarean section, Pabal significantly reduces the need for additional uterotonics and additional uterine massage compared with oxytocin. Carbetocin may also be associated with lower levels of perceived post-operative pain following caesarean delivery than oxytocin. Room temperature stable Pabal is available in vials containing 1ml and can be stored at up to 30oC.