Crofelemer is a non-antibiotic drug currently conditionally approved by FDA to treat and manage Chemotherapy Induced Diarrhoea in unfortunate pets undergoing chemotherapy.
Diarrhoea is one of the most common side effects of a chemotherapy and at times the cases are so severe that chemotherapy may need to be stopped to let pets recover from diarrhoea.
Crofelemer is a botanical, prescription medicine commonly used in human beings for similar indication and Jaguar Animal Health has formulated it as a delayed release oral tablets under brand name – Canalevia-CA1 with already a conditional approval for CID.
The present application submitted to US FDA attempts to achieve full, extensive approval for CANALEVIA-CA1, after having established its safety and efficacy. Jaguar Animal Health has based its filing on a recently concluded pivotal efficacy trial, demonstrating achievement of end results.
This pivotal study demonstrated that dogs suffering from CID, who were treated with Canalevia-CA1 twice daily at the onset of diarrhoea had, at the end of 3 days of treatment, an average daily stool that was regarded as normal. Moreover, in a survey of pet owners, at the end of the study, 77% of the owners of dogs participating in the study reported that they believed Canalevia-CA1 was an effective treatment for their dog’s CID.
Additionally, around 40% of dog owners reported that Canalevia-CA1 completely resolved their dog’s CID. In comparison, only 10.5% of owners reported complete resolution in their dog’s CID without the use of any CID treatments. This study was carried out at veterinary oncology clinics across US and Jaguar Anima Health is hopeful of favourable decision basis the data from this efficacy study.
