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Jaguar Health Announces FDA Activation of Third-Party Investigational New Drug (IND) Application for Evaluation of Crofelemer for Treatment of Uncontrolled Diarrhea in Patient with Short Bowel Syndrome (SBS)
Napo Pharmaceuticals, a Jaguar Health company and the manufacturer of crofelemer, is supporting this physician-generated INDSAN FRANCISCO, CA / ACCESSWIRE /
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Napo Pharmaceuticals, a Jaguar Health company and the manufacturer of crofelemer, is supporting this physician-generated INDSAN FRANCISCO, CA / ACCESSWIRE / August 1, 2023 / Jaguar Health (NASDAQ:JAGX) (\"the Company\") today announced the activation by the U.S. Food and Drug Administration (FDA) of a physician-requested Investigational New Drug (IND) application to evaluate crofelemer for treatment of uncontrolled diarrhea in a patient with short bowel syndrome (SBS), a rare and complex condition characterized by diarrhea and/or severe malabsorption of fluids and nutrients. Napo Pharmaceuticals, a Jaguar company, is supporting this investigator-initiated trial of crofelemer, the Company's oral anti-diarrheal prescription drug.\"I am very happy that this IND has been acknowledged by the FDA and that this study to evaluate use of crofelemer to address uncontrolled diarrhea in my patient with SBS may proceed,\" said Charles Conte, MD, Chief of Surgical Oncology at Northwell Health. \"SBS resulting from surgical bowel resection due to cancer diagnosis is a debilitating condition. Our hope is that by potentially relieving the debilitating diarrhea with crofelemer treatment, we can improve the patient's nutritional status and prevent exposing the patient to the toxicities associated with parenteral nutrition.\"\"Napo Pharmaceuticals received a request from Dr. Conte for emergency use of crofelemer to address the urgent medical need of an SBS patient's deteriorating condition due to severe diarrhea, with the goal of keeping the patient off of parenteral nutrition (PN) and/or minimizing PN requirements,\" said Pravin Chaturvedi, PhD, Jaguar's Chair of the Scientific Advisory Board and Chief Scientific Officer. \"We are pleased to provide support for this study.\"Some SBS patients are subject to intestinal failure, often requiring PN from a few to up to 7 days a week. Intestinal failure is associated with significant morbidity and mortality; and high medical expenses associated with PN. SBS patients with intestinal failure also have severe chronic diarrhea, and the associated sequelae from diarrhea, including significant dehydration, metabolic acidosis or alkalosis and malnutrition, and other secondary symptoms, and these symptoms emerge either early or late, and many times become life-threatening.In June 2023, Napo Pharmaceuticals subm...