FDA Conditionally Approves First Oral Tablet to Treat Chemotherapy-Induced Diarrhea in Dogs

For immediate release: December 21, 2021

Today the US Food and Drug Administration conditionally approved Canalevia-CA1 (Crofelemer sustained-release tablets) for the treatment of chemotherapy-induced diarrhea in dogs. This is the first treatment approved for this condition.

“Diarrhea is a common side effect of chemotherapy in dogs that can be severe enough to have to stop cancer treatment. Chemotherapy drugs often have potential side effects, but unlike human medicine, where patients are willing to tolerate some discomfort in exchange for a possible cure, the primary purpose of treating cancer in dogs and other pets is to help them survive without increasing the quality of life affect and comfort, “said Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine. “This new drug provides veterinarians and dog owners with yet another tool to control the side effects of chemotherapy in dogs undergoing such treatment.”

Canalevia-CA1 is only available by prescription because of the professional veterinary expertise required to properly diagnose the cause of diarrhea and monitor dogs receiving chemotherapy. Canalevia-CA1 is an oral tablet that can be prescribed for home treatment.

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The active substance in Canalevia-CA1 is crofelemer, which is approved for use in humans to treat non-infectious diarrhea in adults with HIV / AIDS who are receiving antiretroviral therapy. In humans, Crofelemer works by inhibiting the secretion of chloride ions and water by intestinal epithelial cells, thereby normalizing the gastrointestinal tract. The drug is believed to work similarly in dogs.

Canalevia-CA1 received conditional approval through the Minor Use / Minor Species pathway, which is an option for medicinal products for minor uses in major animal species (dogs, cats, horses, cattle, pigs, turkeys, and chickens) or minor species. Canalevia-CA1 qualified for conditional approval because the FDA estimates that only about 1% of dogs in the US are diagnosed with malignant neoplasia (cancer) each year, and that not all treated dogs have chemotherapy-induced diarrhea. Therefore, the agency estimates the incidence of chemotherapy-induced diarrhea in dogs in the United States to be less than 70,000 dogs, which qualifies it as a minor use in one of the major animal species.

Conditional approval allows a veterinary drug sponsor to legally market their product after demonstrating that the drug is safe and manufactured in accordance with full regulatory standards and there is reasonable expectation of the drug’s effectiveness. The initial conditional admission is for one year with the option of a four-year extension. During this time, the Veterinary Medicines Sponsor must demonstrate active progress in demonstrating efficacy for full approval. The veterinary drug sponsor has five years after receiving conditional approval to obtain full approval, or it may no longer be marketed.

The reasonable expectation of efficacy of Canalevia-CA1 was established in a study with 24 dogs (12 treated and 12 control dogs). A dog was considered a treatment success if its diarrhea disappeared and did not recur during the three-day study. The resolution of diarrhea was defined as a feces score of one (well-formed stool) or two (soft or very soft, moist stool with no clear shape). On the third day, 9 of 12 dogs (75%) in the treated group were successful compared to 3 of 12 dogs (25%) in the control group. In addition, 4 of the 12 dogs (33%) in the treated group had diarrhea resolved after 48 hours, compared to none of the dogs in the control group.

The most common side effects in the laboratory and field studies were abnormal faeces (soft, watery, slimy, discolored faeces), decreased appetite and activity, and vomiting.

Veterinarians should inform owners of the possible side effects before using the drug. The FDA encourages dog owners to work with their veterinary team to report any adverse events or side effects that may be related to the use of any drug, including Canalevia-CA1.

The FDA has granted Conditional Approval for Canalevia-CA1 to Jaguar Animal Health.

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The FDA, an agency of the US Department of Health, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety of our country’s food supplies, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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  December 21, 2021