Pharmaceuticals group Dechra has received approvals from both the US Food and Drug Administration (FDA) and the UK Veterinary Medicines Directorate (VMD) for its specialist product Osphos.

Osphos (clodronate injection) is used for the control of clinical signs associated with navicular syndrome in horses. In the majority of Europe, the horse is classed as a food producing species therefore we have had to conduct additional studies relating to maximum residue limits for food safety. The studies are now complete and the European dossier will be filed imminently.

“Osphos represents a significant product opportunity to Dechra with estimates that navicular syndrome is responsible for one third of all chronic forelimb lameness in adult horses,” says Ian Page, CEO of Dechra. “The product will be manufactured from June 2014 and we anticipated launch in both the U.S. and U.K. at the beginning of our new financial year.”

Osphos (clodronate injection) is an injectable bisphosphonate that inhibits the bony resorption in the navicular bone that leads to pain and lameness in the forelimbs of horses affected by navicular syndrome, according to Dechra.

Osphos has a direct effect on osteoclasts and also binds calcium phosphate crystals in the bone matrix, according to Dechra. Osphos has the advantage of intramuscular injection versus other currently approved bisphosphonates, which require a lengthy intravenous infusion protocol for administration, according to Dechra.

Clinical improvement is most evident at 2 months post-treatment with 74.7% of the horses experiencing improvement in their lameness score, according to Dechra. Of the horses that responded to treatment with Osphos in the field study, 65% maintained their level of improvement through the six month evaluation.

For horses that initially respond to Osphos, it may be re-administered at three- to six-month intervals based on recurrence of clinical signs, according to Dechra.

Dechra has acquired rights to operate within a third party’s patent, which covers bisphosphonates for the treatment of navicular disease and they also have two patents granted in the E.U. and U.S. and further international patents pending for our specific product and its application.