Fulyzaq Approved for Diarrhea in People With HIV/AIDS
WEDNESDAY, Jan. 2 -- The first medication to treat diarrhea in people with HIV/AIDS who take antiretroviral drugs has been approved by the U.S. Food and Drug Administration.
Fulyzaq (crofelemer) is sanctioned for people whose diarrhea is not caused by an infection or gastrointestinal disorder but by the antiretroviral drugs used to combat HIV/AIDS, the FDA said in a news release. The drug is derived from the red sap of the Croton lechleri plant.
Fulyzaq's safety and effectiveness were evaluated in a clinical study involving 374 people who were HIV-positive, on stable drug therapy and who had had diarrhea for one month or longer. About 17.6 percent of people who took Fulyzaq had a positive "clinical response," compared with a positive response among 8 percent of people who took a placebo.
All participants in the study were tested to confirm that their symptoms were not caused by an infection or gastrointestinal disease, the FDA said. Common side effects to Fulyzaq's use were upper respiratory tract infection, bronchitis, cough, flatulence and an increase in the liver enzyme bilirubin.
The drug is distributed by Salix Pharmaceuticals, based in Raleigh, N.C.
The FDA has more about this approval.
Posted: January 2013