Jaguar Health and Napo Pharmaceuticals announced that Mytesi (crofelemer) has received Orphan Drug designation from the Food and Drug Administration (FDA) for the treatment of short bowel syndrome (SBS). Mytesi, a first-in-class anti-secretory agent, is currently approved for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS receiving antiretroviral therapy.

SBS is characterized by malabsorption of fluids and nutrients due to congenital deficiencies with symptoms that include debilitating diarrhea, malnutrition, and dehydration.

Dr. Pravin Chaturvedi, Chair of Napo’s Scientific Advisory Board said, “We believe [Mytesi] may have considerable potential for managing the fluid loss and dehydration associated with chronic diarrhea that leads to devastating health implications in these pediatric patients.” 

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Clinical studies of Mytesi have shown that the most common adverse reactions were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough, and flatulence (3.1%). 

“We welcome the opportunity to participate in the investigation of a novel drug to address the devastating diarrhea and dehydration caused by this lifelong disease for which there is currently no available treatment,” said Dr. Mohammed Miqdady, Chief of Pediatric Gastroenterology, Hepatology & Nutrition at Sheikh Khalifa Medical City in Abu Dhabi and advisor to Napo. 

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