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Ferring Pharma's new room temperature stable formulation of Pabal approved through EU

 

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Ferring Pharmaceuticals, a research-driven, specialty biopharmaceutical group active in global markets, announced that EU has approved its new room-temperature-stable formulation of Pabal (carbetocin) for intravenous (IV) administration.

Pabal is a long-acting synthetic octapeptide analogue of human oxytocin with agonist properties.  Its Half-life is approximately 40 minutes. It is indicated for the prevention of uterine atony and postpartum hemor-rhage following elective caesarean section. approximately 80% of postpartum haemorrhage (PPH) case is due to Uterine atony . Postpartum hemorrhage (PPH) is the leading cause of maternal mortality. All women who carry a pregnancy beyond 20 weeks’ gestation are at risk for PPH and its sequelae. Bleed of 500 mL or more in vaginal deliveries and in excess of 1000 mL in abdominal deliveries cause PPH. Active management of the third stage of labour 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.

The new formulation of Pabal is the first long-acting, room-temperature-stable oxytocic agent to be approved for this condition. This Room-temperature-stable Pabal is expected to come in Europe during the second quarter of 2015.

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) working along with the World Health Organization (WHO) of making the room-temperature-stable formulation of carbetocin for intramuscular administration available in the public sector of developing countries at an affordable and sustainable price. World Health Organization statistics suggest that 25% of maternal deaths are due to PPH. To evaluate the effectiveness of this formulation (as compared to oxytocin) in preventing uterine atony, WHO will conduct a multi-country clinical trial in the third stage of labour in women who have delivered vaginally. The study will take place in approximately 30,000 women  of 11 countries around the world.

Since its introduction in 1999, Pabal has been approved for the prevention of uterine atony in over 70 countries. A single IV dose of 100mcg, 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. Pabal significantly reduces the need for additional uterotonics in women undergoing caesarean section, compared with oxytocin. Room temperature stable Pabal is available in vials containing 1ml and can be stored at up to 30oC. Pabal is not recommended for elderly patients.


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