Napo Pharmaceuticals files CMC supplement with FDA for Mytesi
Jaguar Health announced that its wholly-owned subsidiary, Napo Pharmaceuticals has filed a Chemistry, Manufacturing, and Controls supplement with the U.S. Food & Drug Administration for six-tablet bottles of Mytesi, Napo's FDA-approved human drug, in preparation for Napo's planned national sample campaign. Mytesi is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar and Napo are pursuing a follow-on indication for Mytesi in chemotherapy-induced diarrhea, an important supportive care indication for patients undergoing primary or adjuvant chemotherapy for cancer treatment. Mytesi is also in development for rare disease indications for infants and children with congenital diarrheal disorders and short bowel syndrome; for irritable bowel syndrome; for supportive care for inflammatory bowel disease; and as a second-generation anti-secretory agent for use in cholera patients. Mytesi has received orphan-drug designation for SBS. The planned sample bottles will contain enough Mytesi tablets for three days of use. To implement the filing, Napo produced stability data in support of a one-year shelf life for the contents of the sample bottles.