Jaguar Animal Health (NASDAQ:JAGX) has submitted a formal request to the FDA’s Center for Veterinary Medicine for a determination whether Canalevia qualifies under the requirements of the Minor Use and Minor Species (MUMS) Animal Health Act for the indication of exercise-induced diarrhea (EID) in dogs.
MUMS designation is modeled on the orphan drug designation for human drug development and offers possible financial incentives to encourage MUMS drug development, such as the availability of grants to help with the cost of developing the MUMS drug.
Canalevia, Jaguar’s lead drug product candidate, under investigation for various types of diarrhea in dogs, is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree.
Numerous clinical trials have shown significant beneficial results in the use of crofelemer in the treatment of secretory diarrhea.
Jaguar has already received MUMS designation for Canalevia for use in dogs with chemotherapy-induced diarrhea (CID), which the company expects will be the first indication available commercially in the next year.
“If we are successful in obtaining MUMS designation for Canalevia for use in dogs with EID, it is our hope that this could lead to access to Canalevia, under conditional approval, for dogs for this indication also within a year,” Lisa Conte, president and CEO, said in a statement.