Crofelemer, Jaguar Health’s Prescription Drug Conditionally Approved by the FDA for Chemotherapy-Induced Diarrhea in Dogs, is the Subject of the Company’s Investigational New Animal Drug Application for the Indication of General Diarrhea in Dogs

Diarrhea is one of the most common reasons for veterinary visits for dogs and the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved anti-secretory agents to treat canine diarrhea

SAN FRANCISCO, CA / ACCESSWIRE / May 6, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it has established a new Investigational New Animal Drug (INAD) file with the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA) for the company's novel plant-based prescription drug crofelemer to treat general, non-infectious diarrhea in dogs.

Crofelemer delayed-release tablets, under the name Canalevia-CA1, received conditional approval in December 2021 from the FDA for the treatment of chemotherapy-induced diarrhea (CID) in dogs.

"We're very pleased to have established this new INAD file," said Michael Guy, DVM, MS, PhD, Jaguar's Vice President of Preclinical and Nonclinical Studies. "We've been pleased with the marketplace reception of crofelemer for treatment of CID in dogs, and believe there is clearly an unmet need for a product to treat general, non-infectious diarrhea in dogs as well. We estimate that U.S. veterinarians see approximately six million annual cases of acute and chronic diarrhea in dogs, and we look forward to evaluating the possibility of expanding the indication of crofelemer to include treatment of all types of non-infectious diarrhea in dogs. The next step in our development process is to request a pre-submission conference with the CVM to discuss our proposed protocol for the clinical field study for this new indication."

Jaguar previously issued results from a multicenter, randomized, double-blind, controlled proof-of-concept study that assessed the efficacy of crofelemer administered orally in alleviating clinical signs associated with secretory diarrhea in dogs. The study results showed that crofelemer was superior to placebo.

Diarrhea is one of the most common reasons for veterinary office visits for dogs and is the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved anti-secretory agents to treat canine diarrhea. According to the American Veterinary Medical Association, there were an estimated 83 million to 88 million dogs in the United States in 2020, and 45% of U.S. households owned a dog in 2020. Devastating dehydration can occur rapidly for the animal, and the lack of control in urban settings where owners don't have easy access to outdoor facilities is a significant problem for families with dogs.