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Jaguar Health Completes Final Major Regulatory Filing for Conditional New Animal Drug 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 / February 10,
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 / February 10, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX), under its Jaguar Animal Health tradename for the veterinary market, today announced that it has completed filing of the final major regulatory section with the U.S. Food and Drug Administration's (\"FDA\") Center for Veterinary Medicine (CVM) to support conditional new animal drug approval of the company's oral plant-based drug candidate Canalevia (crofelemer delayed-release tablets) to treat exercise-induced diarrhea (EID) in dogs.In December of 2021, Jaguar Animal Health received conditional approval from the FDA for Canalevia™-CA1 for chemotherapy-induced diarrhea (CID) in dogs.\"We are leveraging many of the same major technical sections from our successful CID submission for the proposed EID indication,\" said Dr. Michael Guy, DVM, MS, Ph.D., Jaguar Health's vice president of preclinical and nonclinical studies. \"We expect that Canalevia could receive FDA conditional approval, under the name Canalevia™-CA2, to treat EID in dogs in the fourth quarter of 2022.\"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 though 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.\"Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals (\"Napo\"), currently markets another form of crofelemer, Mytesi®, the only non-opioid oral plant-based medicine approved by the FDA for the treatment of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Crofelemer comes from the Croton lechleri tree, which is responsibly and sustainably harv...