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Jaguar Health's Mytesi Drug Product Now Approved for Sale in Puerto Rico
Puerto Rico Had the 7th Highest Cumulative Rate of HIV Infection in the Nation in 2016SAN FRANCISCO, CA / ACCESSWIRE / September 16, 2019 / Jaguar Health,
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Puerto Rico Had the 7th Highest Cumulative Rate of HIV Infection in the Nation in 2016SAN FRANCISCO, CA / ACCESSWIRE / September 16, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the “Company”) announced today that the Drug and Pharmacy Division of the Government of Puerto Rico Health Department has approved the registration of Mytesi® (crofelemer 125 MG delayed-release tablets), the Company’s FDA-approved drug product indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). The Company’s wholly-owned, human-health focused subsidiary, Napo Pharmaceuticals, Inc. (“Napo”) is now able to begin marketing and selling Mytesi in Puerto Rico, a U.S. territory with a population of approximately 3.4 million people.Based on data from the Centers for Disease Control and Prevention (CDC) comparing all 50 U.S. states, the District of Columbia, and six U.S. dependent areas, in 2016, with an estimated 16,809 adults and adolescents living with an HIV diagnosis, Puerto Rico had the 7th highest cumulative rate of HIV infection in the nation, at a rate of 572.6 per 100,000 lives.1''We’re excited to be able to bring Mytesi to the Puerto Rico HIV population,” Brian Sutton, Napo’s national business director, commented, “and we’re grateful to the multiple HIV treatment centers and clinical sites in Puerto Rico that supported development of Mytesi by participating in the pivotal ADVENT trial.”About Mytesi®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 medici...