Napo Pharmaceuticals announced the availability of Mytesi (crofelemer delayed-release tablets) for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi was formerly marketed under the brand name Fulyzaq.

Crofelemer is a botanical drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. It works by blocking chloride ion secretion and accompanying high volume water loss in diarrhea, normalizing the flow of chloride ion and water in the GI tract.

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The efficacy of Mytesi was evaluated in a randomized, double-blind, placebo-controlled (one month) and placebo-free (five month), multi-center study. The study enrolled 374 HIV-positive patients on stable ART with a history of diarrhea for one month or more. The primary efficacy endpoint was the proportion of patients with a clinical response, defined as less than or equal to 2 watery bowel movements per week during at least 2 of the 4 weeks of the placebo-controlled phase.  A significantly larger proportion of patients in the crofelemer 125mg twice daily group experienced clinical response compared with patients in the placebo group (17.6% vs. 8.0%, 1–sided p < 0.01).

“Some healthcare providers believe that diarrhea is only associated with ART and that newer antiretroviral medications cause less diarrhea.  However, HIV enteropathy, which is chronic diarrhea due to the direct or indirect effects of HIV on the GI tract, is a problem for many HIV+ patients, independent of their ART regimen,” said Rodger D. MacArthur, MD, Professor of Medicine, Division of Infectious Diseases at the Medical College of Georgia, an HIV specialist who was an investigator in and is the author of the ADVENT Trial, the pivotal study that led to regulatory approval of crofelemer.

Mytesi is available in a 125mg delayed-release tablet in 60-count bottles.

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