FDA APPROVES CROFELEMER AS FIRST – EVER ORAL BOTANICAL DRUG

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Crofelemer

Crofelemer is a Amazon tree-derived medicine cleared for usage in HIV patients with diarrhea. US Food and Drug Administration (FDA) announced its approval of crofelemer (Fulyzaq™, Salix Pharmaceuticals, Ltd., Raleigh, North Carolina) – marking the second time a botanical, and the first time an orally administered botanical, has received drug approval from the Administration

Crofelemer is the first drug to be approved in the United States to treat HIV-associated diarrhea. It is derived from the latex of the South American sangre de drago tree (dragon’s blood, Croton lechleri). A red, blood-resembling latex leaks from the tree when its bark is cut, and it is this substance that contains the novel polymolecular structure crofelemer, originally developed and standardized by Shaman Pharmaceuticals.

Mechanism of action:  Crofelemer is an inhibitor of both cAMP- Stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl) channels and the calcium activated Cl channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl channels and CaCC regulate Cl & fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking the Cl secretion and accompanying high volume water loss in diarrhea normalizing the flow of water and Cl in GI tract.

Indications & Usage: Indicated for symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy.

Dosage & Administration: 125 mg delayed – release tablet taken orally for two times a day with or without food.

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