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Jaguar Health Submits Final Major Regulatory Filing for Approval of Canalevia (Crofelemer) to Treat Exercise-induced Diarrhea in Dogs
Canalevia would be first and only FDA-approved plant-based medicine for working dogs that suffer from diarrheaSAN FRANCISCO, CA / ACCESSWIRE / July 2, 2020 /
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Canalevia would be first and only FDA-approved plant-based medicine for working dogs that suffer from diarrheaSAN FRANCISCO, CA / ACCESSWIRE / July 2, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\") announced today that it has submitted to the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) the final major regulatory filing to support approval of its oral plant-based drug candidate Canalevia™ (crofelemer delayed-release tablets) to treat exercise-induced diarrhea (EID) in dogs.Working dogs, including search and rescue, military and sled dogs, often suffer diarrhea as a result of engaging in long periods of intense, off-leash exercise. \"Elite athletes of all species tend to have more diarrhea than their healthy but more sedentary counterparts, which can interfere with peak physical performance,\" said Dr. Michael Davis, DVM, Ph.D., DACVIM, DACVSMR, a veterinary physiologist and board-certified specialist in veterinary internal medicine and veterinary sports medicine at Oklahoma State University, where he conducts research on animal exercise physiology and performance.\"There is a significant need in the world of working dogs for a safe and effective medicine that can reduce the incidence and severity of exercise-induced diarrhea without affecting performance,\" he said.In addition to EID, Jaguar is also seeking conditional approval to market Canalevia for chemotherapy-induced diarrhea (CID) in dogs. \"We are leveraging many of the same major technical sections from our CID submission for the proposed EID indication,\" said Dr. Michael Guy, DVM, Ph.D., Jaguar's vice president of preclinical and nonclinical studies. \"We expect that Canalevia could be available under conditional approval to treat both CID and EID in the first half of 2021.\"\"We're one step closer to introducing our first FDA-approved oral plant-based medicine for animals,\" said Jaguar president and chief executive officer Lisa Conte. \"We believe Canalevia will be an important treatment option for working dogs experiencing EID as well as for the estimated 50,000 dogs that suffer from CID each year. And once CID is under control, dogs may better tolerate their chemotherapy.\"\"We're also excited about the potential to develop crofelemer to treat cancer therapy-related diarrhea in humans. Dogs undergoing chemothera...