Jaguar Animal Health Announces Commercialization of Herbal Prescription Drug Canalevia-CA1 (Crofelemer) for the Treatment of Chemotherapy-Induced Diarrhea (DIC) in Dogs
Canalevia®-CA1 is the first and only treatment for CID in dogs to receive any type of FDA approval
SAN FRANCISCO, Calif./ACCESSWIRE/April 27, 2022/ Jaguar Health, Inc. (NASDAQ: JAGX), operating under its trade name Jaguar Animal Health for the veterinary market, today announced that Canalevia-CA1 (crofelemer delayed-release tablets), the Company’s prescription drug for the treatment of chemotherapy-induced diarrhea (DIC) in dogs, now available from several leading veterinary distributors in the United States Canalevia-CA1 received conditional approval from the FDA on December 21, 2021.
“We are thrilled that Canalevia-CA1 is now available to veterinarians across the country,” said Chip Whitlow, director of sales and marketing for the Animal Health company’s commercial portfolio. “Canalevia-CA1 is an important introduction to prescription drugs for the veterinary community and the thousands of dogs suffering from CID. Canalevia-CA1 can help support dogs’ comfort and quality of life while being treated with chemotherapy, which can help them stay compliant with their life-saving treatment.”
Due to the increasing number of chemotherapeutic agents adopted by veterinary oncologists and general veterinarians, chemotherapy is rapidly becoming the most widely used oncological modality in veterinary medicine. Studies have shown that the incidence of DIC is one of the three most common side effects in dogs undergoing cancer treatment,1 and managing side effects such as DIC can be important in maintaining cancer treatment success. More than half of US veterinarians who responded to a recent Jaguar-sponsored survey reported that DIC interferes with their patients’ chemotherapy treatment plans, indicating an unmet need for an effective product for the treatment of DIC. .
Canalevia-CA1 is a tablet that can be taken orally twice a day and can be used for the home treatment of DIC.
Jaguar Animal Health launched the www.canalevia.com website in December 2021. For veterinarians, the site provides information on the prescription of Canalevia-CA1, data on the pharmacological properties and the new mechanism of action of the active pharmaceutical ingredient in the product, crofelemer, and a list of upcoming veterinary conferences the company plans to attend. For dog owners, the site provides an overview of CID and its negative effects on dogs undergoing chemotherapy.
Crofelemer is a new herbal oral medicine extracted and purified from the sap of the red bark, also called “dragon’s blood”, of the medicinal plant Croton lechleri tree in the Amazon rainforest. Jaguar Health’s wholly-owned subsidiary, Napo Pharmaceuticals, has implemented a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity and support. local and indigenous communities.
Canalevia-CA1 (crofelemer delayed-release tablets) is the first and only herbal oral prescription product conditionally approved by the FDA to treat chemotherapy-induced diarrhea (DIC) in dogs. Canalevia-CA1 is a formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree. Canalevia-CA1 is currently conditionally approved by the FDA under application number 141-552. Conditional approval allows the product to be marketed while Jaguar continues to gather the substantial evidence of efficacy required for full approval. Jaguar has received Minor Use Designation in a Major Species (MUMS) from the FDA for Canalevia-CA1 to treat CID in dogs. The FDA has established a “small number” threshold for minor use in each of the seven major species covered by MUMS. The small number threshold is currently 70,000 for dogs, which is the highest number of dogs that can be affected by a disease or condition in a year and whose use still qualifies as use minor.
Important safety information about Canalevia-CA1
For oral use in dogs only. Do not use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a safe place, out of the reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs with known hypersensitivity to crofelemer. Before using Canalevia-CA1, exclude infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common side effects included decreased appetite, decreased activity, dehydration, abdominal pain and vomiting.
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of federal law to use this product other than as directed on the label.Conditionally approved by the FDA pending full demonstration of efficacy under application number 141-552.
About Jaguar Health, Jaguar Animal Health, Napo Pharmaceuticals and Napo Therapeutics
Jaguar Health is a commercial-stage pharmaceutical company focused on developing new herbal, non-opioid and sustainably-derived prescription medicines for people and animals with gastrointestinal disorders, including chronic diarrhea and debilitating. Jaguar Animal Health is a trading name of Jaguar Health. Jaguar Health’s wholly-owned subsidiary, Napo Pharmaceuticals, focuses on the development and commercialization of proprietary plant-based human gastrointestinal pharmaceuticals from plants responsibly harvested from rainforest areas. Jaguar Health is the majority shareholder of Napo Therapeutics SpA (f/k/a Napo EU SpA), an Italian company established by Jaguar Health in Milan, Italy, in 2021, which focuses on expanding access to crofelemers in Europe.
For more information about Jaguar, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.
Certain statements contained in this press release constitute “forward-looking statements”. These include statements regarding Jaguar Animal Health’s expectation that Canalevia-CA1 can help dogs adhere to their chemotherapy treatment. In some cases, you can identify forward-looking statements by words such as “may”, “will”, “should”, “expect”, “plan”, “aim”, “anticipate”, ” could”, “intend”, “target”, “project”, “consider”, “believe”, “estimate”, “predict”, “potential”, or “continue” or the negative form of these terms or other similar expressions. The forward-looking statements contained in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections regarding future events. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Some of the factors that could affect our actual results are included in periodic reports on form aire 10-K and Form 10-Q that we file with the Securities and Exchange Commission. Except as required by applicable law, Jaguar does not intend to publicly update or revise any forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances or otherwise. .
1 Mason SL, Grant IA, Elliott J, Cripps P, Blackwood L. Gastrointestinal toxicity after administration of vincristine or cyclophosphamide with or without maropitant in dogs: a prospective randomized controlled study. J Small Anim Pract. 2014;55:391-398
Source: Jaguar Health, Inc.
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