First approved botanical drug.
The news was released on December 31st 2012 by the U.S. food and drug administration. This is the first approved botanical drug to treat diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. There were no FDA-approved therapies for HIV-associated diarrhea prior to that.
Human immunodeficiency virus or HIV is the virus that can lead to acquired immune deficiency syndrome, or AIDS. In 2007, 35,962 cases of AIDS were diagnosed and 14,110 deaths reported among people living with HIV in the United States.
For more information you may contact:
- Morgan Liscinsky at 301-796-0397 or consumer inquiries at 888-INFO-FDA.
- E-mail address: morgan.liscinsky@fda.hhs.gov
Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.
Croton lechleri tree.
The name of the drug called fulyzaq or crofelemer is derived from the red sap of the Croton lechleri tree. The red cut like latex of the South American sangre de drago tree or dragon's blood otherwise known as Croton lechleri is being used. It contains specific polymolecular structure called crofelemer.
The safety and efficacy of Fulyzaq were established in a clinical trial of 374 HIV-positive patients on stable antiretroviral therapy with a history of diarrhea lasting one month or longer. Fulyzaq is distributed by Salix Pharmaceuticals, based in Raleigh, N.C. under license from Napo Pharmaceuticals, Inc.
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