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Summary Of Crofelemer Clinical Studies In Humans
Clinical Phase Indication # of Patients Citation
3 HIV-associated diarrhea Crofelemer (136)
Placebo (138)
MacArthur RD et al. HIV Clinical Trials. 2013.
3 HIV-associated diarrhea Crofelemer (251) Unpublished Data on File, Napo Pharmaceuticals.
3 HIV-associated diarrhea Crofelemer (302)
Placebo (98)
Hoop RS  et al. Poster, DIA 2005.
2 HIV-associated diarrhea Crofelemer (43)
Placebo (42)
Holodniy M  et al. Am J Gastroenterol. 1999.
Investigational Uses of Crofelemer In Humans
2 Severe Cholera Crofelemer (80)
Placebo (20)
Bardhan PK et al. Abstract, 13th ICEID Pacific Rim 2009.
2 Acute Watery Diarrhea Crofelemer (51)
Placebo (47)
Bardhan PK et al. Abstract, 13th ICEID Pacific Rim 2009.
2 Traveler’s Diarrhea Crofelemer (140)
Placebo (44)
DiCesare D et al. Am J Gastroenterol. 2002.
2 IBS-D Crofelemer (183)
Placebo (61)
Lembo AJ et al. Oral session, DDW 2007.
1 Pediatric Safety 30 patients from 3-24 months Connor JD Unpublished data. Napo Pharmaceuticals. 1995.

Important Safety Information:

Mytesi® (crofelemer 125 mg delayed-release tablets) is approved for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy. Rule out infectious etiologies of diarrhea before starting Mytesi® in order to avoid the risk of potential worsening of disease due to delay of appropriate therapy. The most common adverse events (incidence ≥ 3%) reported in Mytesi® clinical trials were upper respiratory tract infection, bronchitis, cough, flatulence, and increased billirubin.

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