Salix: FDA again extends review of diarrhea drug
RALEIGH, N.C. (AP) — Salix Pharmaceuticals Ltd. said Wednesday that the Food and Drug Administration will need until early 2013 to complete a review of crofelemer, a drug that is designed to treat diarrhea in patients taking HIV and AIDS drugs.
Salix said it is still discussing production and control of the main ingredient in the drug, which is made from the purified sap of a South American tree. The FDA was due to make a decision on the drug by Wednesday and is now expected to make a ruling by the end of the first quarter of 2013. This is the second time the agency has extended its review, as it originally set a target date of June 5.
Crofelemer is intended to treat diarrhea in patients with HIV or AIDS who are on anti-retroviral therapy. Salix said many patients who are taking anti-retroviral drugs experience episodic or chronic diarrhea, which can lead to weight loss and affect compliance with the treatment.
The company said that crofelemer would be the first FDA-approved botanical drug that is intended to be taken orally. The active ingredient in the drug is derived from the sap of a tree called Croton lechleri, commonly known as "dragon's blood" because of the red color of the sap. The ingredient is isolated and purified after the sap is extracted.
Shares of Salix Pharmaceuticals lost 51 cents to $43.44 in midday trading.