FDA approves first anti-diarrheal drug for HIV/AIDS patient, Salix Pharma's Fulyzaq

Continuing the flurry of 2012 year-end drug approvals, the US Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. The drug will be distributed by Salix Pharmaceuticals (Nasdaq: SLXP), under license from fellow USA-based Napo Pharmaceuticals.

Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies. Fulyzaq is intended to be used in HIV/AIDS patients whose diarrhea is not caused by an infection from a virus, bacteria, or parasite. Patients take Fulyzaq two times a day to manage watery diarrhea due to the secretion of electrolytes and water in the gastrointestinal tract.

Salix has said that the US HIV-associated diarrhea market represents a $300 million-a-year opportunity. However, analysts estimated that crofelemer may add about $18 million in sales in 2013 and $26 million in 2014, according to the average of seven estimates compiled by Bloomberg.