FDA clears Salix anti-diarrheal for HIV patients

The Food and Drug Administration has approved the first anti-diarrheal drug for HIV/AIDS patients, Salix Pharmaceuticals Ltd.‘s Fulyzaq.

The drug, also known as crofelemer, is meant to relieve symptoms of noninfectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy. Fulyzaq is derived from the red sap of the Croton lechleri plant and is the second botanical prescription drug approved by the FDA.

The safety and efficacy of the drug 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. The trial’s results showed that nearly 18% of patients taking Fulyzaq twice daily experienced fewer watery bowel movements weekly compared with 8% of patients taking a placebo.

Salix was granted FDA priority review status in February for its Crofelemer 125 milligram tablets, though the FDA had extended its review past its original goal date of June 5.

Such reviews are given for drugs with potential that offer major advances in treatment or provide a treatment where there isn’t an existing adequate therapy.

Salix, which focuses on treatments for gastrointestinal diseases, has seen its revenue jump in recent quarters, helped by sales of Xifaxan, or rifaximin, an antibiotic used to treat hepatic encephalopathy, as well as travelers’ diarrhea.

Last month, the company reported its third-quarter revenue jumped 27%, though profits fell 52% amid higher expenses.

The drug developer’s shares were up 1.5% to $40.27 in recent trading. The stock has fallen 16% this year.


By Nathalie Tadena

Provided by ArmMed Media