Salix: FDA again extends review of diarrhea drug

RALEIGH, N.C. — 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. 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.

Shares of Salix Pharmaceuticals lost 67 cents to $43.28 in morning trading.