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HerbalEGram: Volume 6, Number 6, June 2009
Trials Show Crofelemer is Effective for Treating Diarrhea
Associated with Cholera and Other Infectious Pathogens
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According to a new clinical trial presented by Napo Pharmaceuticals, Inc (Napo) at the 13th International Conference on Emerging Infectious Diseases in the Pacific Rim (Kolkata, India; April 6–9, 2009), Napo’s crofelemer product is superior to placebo in treating infectious diarrhea and cholera.1
Crofelemer is a large purified proanthocyanidin oligomer isolated from the red latex of the sangre de drago or “dragon’s blood” tree (Croton lechleri) from South America, where the latex has been used for centuries by local healers for various maladies, including diarrhea.2,3
In this randomized placebo controlled trial the effects of crofelemer were tested on patients with acute dehydrating watery diarrhea caused by bacterial infections such as Escherichia coli (E-coli) and Vibrio cholerae (cholera).1 Cholera is an infection that causes severe diarrhea which results in severe dehydration and which can lead to death, sometimes within the first 12 hours of infection. Since crofelemer has an anti-secretory mechanism of action which blocks chloride ions and subsequent water secretion, this keeps the gut from losing too much excess fluid, which prevents dehydration-related death.3,4 Crofelemer also acts locally on the gastrointestinal tract, instead of being absorbed into the body, which gives it a higher level of efficacy than other treatments, and limits the potential for adverse effects. Most antidiarrheal agents paralyze or slow the gut, causing constipation, and cannot be taken for more than 24 hours.
In this study, a group of 98 Indian patients received 250 mg of crofelemer or placebo every 6 hours for 2 days.1 Simultaneous use of antibiotics was not allowed in this study. Forty-seven patients were in the placebo group with 51 in the crofelemer group. Crofelemer was well-tolerated with no adverse effects. However, 12 patients in the placebo group required antibiotic rescue therapy compared to only 4 patients in the crofelemer group. Overall, a clinical success was achieved in 75% of the crofelemer group as compared to only 37% in the placebo group.
In another recent clinical trial presented at the same conference, 100 adult patients from Bangladesh, ages 18–55 with dehydrating diarrhea and confirmed cholera, were given crofelemer or placebo one hour after receiving azithromycin and rehydration therapies. The goal was to see if crofelemer was safe and effective to administer during the first 24 hours after patients received the above therapies. Crofelemer was well-tolerated with no adverse effects and showed a strong trend in reduction of watery stool.
So far crofelemer has shown overall effectiveness in approximately 1,700 randomized patients in double-blind, placebo-controlled trials involving HIV/AIDS-related diarrhea, infectious diarrhea, severe cholera, traveler’s diarrhea, diarrhea-predominant irritable bowel syndrome, and safety in patients as young as three months of age, with no apparent adverse effects.4
The latex from which crofelemer is derived is sustainably harvested from wild and cultivated trees in Colombia, Ecuador and Peru. Napo Pharmaceuticals collaborates with local people and small businesses to harvest these trees sustainably. To date, Napo and its collaborators have reforested more then 300,000 trees in several locations.5 The tree planting has been conducted with a variety of stakeholders, including local indigenous communities. The work on harvesting and sustainably managing C. lechleri provides income to people living in tropical forests who dedicate their time to a number of subsistence activities but who also seek income for all of the basic requirements of life, such as schools, tools, clothing, and health care, according to Napo’s Vice President of Sustainable Supply and Ethnobotanical Research Steven King, PhD.
“We are proud to work in partnership with local people and businesses to provide alternatives to deforestation,” said Dr. King. “Napo has partnered with the nonprofit, the Healing Forest Conservancy, to recognize the indigenous knowledge and return benefits to the cultures and governments that have contributed to the development of this product.”
More information about current clinical trials on crofelemer is available at the Napo Pharmaceuticals Web site. Information about the current Phase 3 clinical trial studying the effectiveness of crofelemer on HIV-associated diarrhea, which is recruiting participants now, can be found at www.adventstudy.com or www.clinicaltrials.gov.
—Kelly Saxton Lindner
References
1. Bardhan P, Sharma A, Bolmall C, Dinakaran N, Rajadhyakshaya G, Khan W, et al. Safety and efficacy of a novel anti-secretory anti-diarrheal agent crofelemer (NP-303). In the treatment of adult acute infectious diarrhea and cholera, with or without the use of antibiotics. 13th International Conference on Emerging Infectious Diseases in the Pacific Rim—Focused on Enteric Diseases [abstract book]. Kolkata, India; April 6–9, 2009.
2. Jones K, Review of Sangre de Drago (Croton lechleri) A South American tree sap in the treatment of diarrhea, inflammation, insect bites, viral infections, and wounds: Traditional uses to clinical research. J Alt Compl Med. November 6, 2003;9(6):877-896.
3. Saxton K. Company Seeks Patients for Clinical Trial on Natural Pharmaceutical for HIV-related Diarrhea. HerbalEGram. July 2008; 5(7). Available at: http://cms.herbalgram.org/heg/volume5/07%20July/Crofelemer.html.
4. Crofelemer Fact sheet. Napo Pharmaceuticals, Inc. Website. Available at http://www.napopharma.com/products/crofelemerFS2.pdf. Accessed May 21, 2009.
5. Sustainability page. Napo Pharmaceuticals, Inc. Website. Available at http://www.napopharma.com./products/sustainability.html. Accessed May 21, 2009.
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