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Jaguar Health Clears Important Hurdle on Path to Approval of Canalevia (Crofelemer) to Treat Exercise-Induced Diarrhea (EID) in Dogs
Canalevia is the first and only oral plant-based prescription drug candidate for EID in dogs Diarrhea is a common problem among working dogs subjected to
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Canalevia is the first and only oral plant-based prescription drug candidate for EID in dogs Diarrhea is a common problem among working dogs subjected to intense, long-duration off-leash exerciseSAN FRANCISCO, CA / ACCESSWIRE / May 12, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\") announced today that it has cleared an important regulatory hurdle in the Company's effort to gain U.S. Food and Drug Administration approval to market Canalevia™ (crofelemer delayed-release tablets), the Company's oral plant-based prescription drug candidate, for the treatment of exercise-induced diarrhea (EID) in dogs.Jaguar has been informed by the FDA's Center for Veterinary Medicine (CVM) that the Environmental Impact technical section has been deemed Complete as part of the Company's application for conditional approval of Canalevia for EID under the Minor Use/Minor Species (MU/MS) section of The Minor Use and Minor Species Animal Health Act of 2004. This section provides an assessment of a drug's potential direct and indirect effect on the environment.Working dogs - such as sled dogs and military 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, and while diarrhea may not be life-threatening, it is significant if the goal is 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 product that can reduce the incidence and severity of exercise-induced diarrhea without affecting performance,\" he said.In addition to EID, Jaguar also is seeking conditional approval from CVM to market Canalevia for cancer-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, MS, PhD, Jaguar's vice president of preclinical and nonclinical studies. \"If we are successful, Canalevia could be available under conditional approval for EID or CID in first h...