(RxWiki News) This week, the US Food and Drug Administration announced approval for Fulyzaq, a drug designed to treat symptoms of diarrhea in HIV/AIDS patients. It's the first drug for this purpose to win FDA approval.
Diarrhea is common among people with HIV and AIDS, and it can become a chronic condition. It's also the reason why many patients stop using or switch their medications that treat HIV/AIDS.
Fulyzaq, the brand name for crofelemer, should be taken two times a day to manage watery diarrhea by patients whose symptoms are not caused by an infection from a bacteria, virus or parasite.
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Fulyzaq is designed to treat diarrhea that's caused by the secretion of electrolytes - salts used by the body's cells - and water from the gastrointestinal tract, according to the FDA release. HIV patients commonly experience electrolyte disturbances due to changes in the way their bodies function with the virus.
Fulyzaq is also unique in the way it is produced. It's the second “botanical” drug to be approved by the FDA. A botanical drug is “a complex mixture” that's made from one or more plant materials, which have been purified to varying degrees.
Makers of botanical drugs have to demonstrate the purity of their raw materials and demonstrate good agricultural and collection practices, as well as the effectiveness and safety of their drug.
Fulyzaq is made from the red sap of a plant called Croton lechleri. It's distributed by Saliz Pharmaceuticals.
Clinical trials prior to FDA approval found that 17.6 percent of patients who took Fulyzaq for watery diarrhea had symptoms improve, compared to only 8 percent who took a placebo. For some patients, the drug's effects lasted up to 20 weeks.
The FDA advises healthcare professionals to test their patients to confirm that the condition does not come from a bacteria, virus, or parasite before prescribing the drug. Side effects may include upper respiratory tract infection, bronchitis, cough, flatulence, and increased levels of the liver enzyme bilirubin, according to the FDA news release.
Cost and insurance coverage information on Fulyzaq is not yet available.