Jaguar Health Clears Important Hurdle on Path to Approval of Canalevia (Crofelemer) to Treat Exercise-Induced Diarrhea (EID) in Dogs
- Canalevia is the first and only oral plant-based prescription drug candidate for EID in dogs
- Diarrhea is a common problem among working dogs subjected to intense, long-duration off-leash exercise
Jaguar has been informed by the FDA's
Working dogs - such as sled dogs and military dogs - often suffer diarrhea as a result of engaging in long periods of intense, off-leash exercise. "Elite athletes of all species tend to have more diarrhea than their healthy but more sedentary counterparts, and while diarrhea may not be life-threatening, it is significant if the goal is peak physical performance," said Dr.
"There is a significant need in the world of working dogs for a product that can reduce the incidence and severity of exercise-induced diarrhea without affecting performance," he said.
In addition to EID, Jaguar also is seeking conditional approval from CVM to market Canalevia for cancer-induced diarrhea (CID) in dogs. "We are leveraging many of the same major technical sections from our CID submission for the proposed EID indication," said Dr.
In addition to confirming the completeness of Jaguar's Environmental Impact technical section for EID, the CVM previously confirmed the completeness of the CMC (Chemistry, Manufacturing and Controls) technical section of the Company's applications for conditional approval of Canalevia for both EID and CID under MU/MS. As previously announced, the CVM has also confirmed the completeness of two of the other three major technical sections of Jaguar's application for Canalevia for CID.
Crofelemer, Canalevia's active ingredient, comes from the Croton lechleri tree, which is responsibly and sustainably harvested in
Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the expectation that Canalevia could be available under conditional approval for EID or CID in first half of 2021. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this 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 the periodic reports on Form 10-K and Form 10-Q that we file with the