Conditionally approved treatment for chemo-induced diarrhea in dogs being studied for general use

Jaguar Health announced the establishment of a new Investigational New Animal Drug (INAD) dossier with the FDA’s Center for Veterinary Medicine for its product Canalevia-CA1 for the treatment of generalized non-infectious diarrhea in dogs.¹ Canalevia-CA1 are extended-release crofelemer tablets that received conditional approval from the FDA in December 2021, the first treatment of its kind for chemotherapy-induced diarrhea (CID) in dogs.²

“We are very pleased to have created this new INAD file,” said Michael Guy, DVM, MS, PhD, Jaguar’s vice president of preclinical and nonclinical studies, in an organizational statement.¹ “We are pleased with the market acceptance of crofelemer for the treatment of CID in dogs and believe there is a clear unmet need for a product to treat generalized, non-infectious diarrhea in dogs.”

According to the organization statement,¹ Jaguar Health has published the results of a multicenter, randomized, double-blind, controlled, proof-of-concept study evaluating the effectiveness of oral crofelmer in relieving clinical symptoms associated with secretory diarrhea in dogs. The results concluded that crofelemer was superior to placebo.

“We estimate that U.S. veterinarians see approximately 6 million cases of acute and chronic diarrhea in dogs annually, and we look forward to exploring the possibility of expanding the indication of crofelemer to the treatment of all types of non-infectious diarrhea in dogs.” “The next step in our development process is to request a pre-trial conference with the CVM to discuss our proposed field clinical trial protocol for this new indication,” Guy continued.

In dogs, diarrhea is one of the most common reasons for a visit to the vet. However, there are currently no FDA-approved antisecretory agents to treat diarrhea in dogs.³ Canalevia-CA1 is the first and currently only oral, herbal prescription for the treatment of CID in dogs to receive conditional approval from the FDA.¹ Crofelember is an active pharmaceutical ingredient that is isolated and purified from the plant Croton lechleri Tree found in the Amazon rainforest.²

Currently, the most common side effects of Canalevia-CA1 include abdominal pain, decreased appetite and activity, dehydration, and vomiting. Check out this episode of dvm360 Live!™ with Sue Ettinger, DVM, DACVIM (Oncology) to learn more about Canalevia-CA1.

References

1. 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 generalized diarrhea in dogs. Press release. Jaguar Health. May 6, 2024. Accessed May 6, 2024. https://jaguarhealth.gcs-web.com/news-releases/news-release-details/crofelemer-jaguar-healths-prescription-drug-conditionally
2. McCafferty C. FDA renews conditional approval of drug for chemotherapy-induced diarrhea. dvm360. December 6, 2023. Accessed May 6, 2024. https://www.dvm360.com/view/fda-renews-conditional-approval-of-medication-for-chemotherapy-induced-diarrhea
3. Yankowicz S. Pet Insurance Company Reports Most Common Vet Visits. dvm360. April 19, 2024. Accessed May 6, 2024. https://www.dvm360.com/view/pet-insurance-company-reports-most-common-veterinary-visits