Conditionally approved treatment for chemo-induced diarrhea in dogs under investigation for general use

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Jaguar Health announced the establishment of a new Investigational New Animal Drug (INAD) file with the FDA’s Center for Veterinary Medicine for its product Canalevia-CA1 to treat general, non-infectious diarrhea in dogs.¹ Canalevia-CA1 are a crofelemer delayed-release 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'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, in an organizational release.¹ "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.

According to the organizational release,¹ Jaguar Health had issued the results from a multicenter, randomized, double-blind, controlled proof-of-concept study assessing the efficacy of crofelmer administered orally in alleviating clinical signs connected to secretory diarrhea in dogs. The findings concluded that crofelemer was superior compared to the placebo.

“We estimate that United States veterinarians see approximately 6 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," Guy continued.

For dogs, diarrhea is one of the most common causes for veterinary visits. However, there is currently no FDA-approved anti-secretory agents to treat canine diarrhea.³ Canalevia-CA1 is the first and currently only oral-plant based prescription to treat canine CID to receive conditional approval from the FDA.¹ Crofelember, is an active pharmaceutical ingredient that is isolated and purified from the Croton lechleri tree that can be found in the Amazon Rainforest.²

Currently, the most common adverse effects for 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 general diarrhea in dogs. News 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 medication 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 veterinary visits. dvm360. April 19, 2024. Accessed May 6, 2024. https://www.dvm360.com/view/pet-insurance-company-reports-most-common-veterinary-visits