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ARA Takes Note: FDA Approves Fulyzaq

Return to The Insider: News & Views

February 28 2013

The Food & Drug Administration’s (FDA) approval of botanical drug Fulyzaq (Crofelemer) is of particular significance to AIDS Research Alliance. ARA was an investigational site in the clinical trial stage of the drug’s development, and ARA is working on its own botanically sourced HIV cure strategy – prostratin.

Fulyzaq is the first drug the FDA has ever approved for the treatment of HIV-related diarrhea. Diarrhea is a common side effect of the drugs prescribed to manage HIV/AIDS. The diarrhea can cause rapid weight loss and depression. The symptoms can be so severe that some patients discontinue or switch their medications prematurely. With Fulyzaq, which is taken twice daily, watery diarrhea caused by electrolyte and water secretion in the gut can be managed, allowing patients to continue their treatment regimens.

Fulyzaq (Crofelemer) marks the second time the FDA has ever approved a botanical drug. Like prostratin, Fulyzaq is plant-derived. It originates from the red sap of the Croton lechleri plant, which grows in northwestern South America. Similar to the Mamala plant, source of prostratin, which was used for centuries by Samoans to treat “yellow fever” or hepatitis, the Croton lechleri plant has a history of use by native healers in the Amazon to treat diarrhea and other health conditions.

ARA Medical Director and Vice President Dr. Stephen Brown commented on the approval, “Crofelemer marks the first new mechanism for the treatment of diarrhea in decades. The clinical trial process took a number of years, and ARA’s involvement goes back to the initial studies conducted by Shaman, and subsequently, to those conducted by Napo and Salix. “ He continued, “We have always considered this drug a very important advance in the treatment of diarrhea. Because many people are uncomfortable talking about this symptom, even with their physicians, recruitment for the studies could have been difficult. Despite this, we were very successful, indicating just how serious and persistent the underlying symptom is.”

The Centers for Disease Control and Prevention estimates that between 150,000 and 180,000 patients on ART suffer from diarrhea (not caused by infection or a gastrointestinal disease).

Salix Pharmaceuticals distributes Fulyzaq in the USA, under license from Napo Pharmaceuticals Inc.

 




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