Business
Jaguar Health Filing for Second Indication of Exercise-Induced Diarrhea in Dogs Under MUMS for Crofelemer
Company's Legacy Animal Health Business Supports Focus on Human Health BenefitsSAN FRANCISCO, CA / ACCESSWIRE / September 18, 2019 / Jaguar Health, Inc.
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Company's Legacy Animal Health Business Supports Focus on Human Health BenefitsSAN FRANCISCO, CA / ACCESSWIRE / September 18, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar" or the \"Company") issued the following updates today regarding the Company's September 11, 2019 pre-submission conference with the U.S. Food & Drug Administration's Center for Veterinary Medicine (CVM) regarding Jaguar's plans to evaluate crofelemer for exercise-induced diarrhea (EID) in dogs.\"Elite athletes of all species tend to have more diarrhea than their healthy but more sedentary counterparts, and while the episodes of diarrhea may not be life-threatening, they are nevertheless significant if the goal is peak physical performance. Thus, there is a considerable need in the world of working dogs for products that can reduce the incidence and severity of exercise-induced diarrhea without affecting performance,\" commented 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.To expedite the submission and application process for the EID indication, Jaguar will be leveraging use of the same major technical sections for EID that have been or will be submitted in support of the Company's application for crofelemer delayed-release tablets (CanaleviaTM) for the indication of chemotherapy-induced diarrhea (CID) in dogs. Jaguar now has two separate indications for Canalevia (crofelemer) being considered for Conditional Approval by the CVM.Jaguar participants in the meeting, which was with representatives from CVM's Office of New Animal Drug Evaluation (ONADE) and the Office of Minor Use/Minor Species (OMUMS), included Michael Guy, DVM, MS, PhD, Jaguar's vice president and clinical veterinarian, David Sesin, PhD, Jaguar's chief manufacturing officer, and Gina Franklin, the Company's vice president of clinical operations.\"We had a very collaborative discussion with the CVM September 11th,\" Dr. Guy commented. \"With regard to Jaguar's application for the proposed EID indication, the CVM agreed in principle to accept and review the same Chemistry, Manufacturing and Controls (CMC), Safety, and En...