Jaguar Health, Inc. announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the design and conduct of a clinical field study of Canalevia-CA1 (crofelemer delayed-release tablets), the company's FDA conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea (CID) in dogs, for full approval of the product. Canalevia-CA1 received conditional approval in December 2021 from the FDA for the treatment of CID in dogs and is available from multiple leading veterinary distributors in the U.S. Conditional approval allows for commercialization of the product while Jaguar continues to collect the substantial evidence of effectiveness required for full approval. FDA's conditional approval allows a drug company to legally sell the animal drug before proving it meets the "substantial evidence" standard of effectiveness for full approval.

The company can also legally promote and advertise the conditionally approved drug for the labeled uses. The conditional approval is valid for one year. The drug company can ask FDA to renew the conditional approval annually for up to four more years, for a total of five years of conditional approval.

To receive a renewal from FDA, the company must show active progress toward proving "substantial evidence of effectiveness" for full approval. During the conditional approval period, the company can legally market the animal drug for the labeled uses while collecting the remaining effectiveness data. After collecting the necessary data, the company then applies to FDA for full approval.

FDA reviews the application and, if appropriate, fully approves the drug. According to the American Veterinary Medical Association, approximately 1 in 4 dogs will, at some stage in their life, develop cancer, and almost 50% of dogs over age 10 will develop cancer.1 According to the National Cancer Institute, which is part of the National Institutes of Health, roughly 6 million new cancer diagnoses are made in dogs each year in the U.S. Due to the increasing number of chemotherapeutic agents being adopted by veterinary oncologists and primary care veterinarians, chemotherapy is fast becoming the most widely used cancer treatment in veterinary medicine. Studies have found the incidence of CID to be one of the three most prevalent side effects in dogs undergoing cancer treatment,2 and managing side-effects such as diarrhea can be important to maintain successful cancer treatment.

More than half of the U.S. veterinarians who responded to a Jaguar-sponsored survey reported that CID interferes with their patients' chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of CID. Canalevia-CA1 is a tablet that can be given orally twice a day and can be used for home treatment of CID.