The Food and Drug Administration has agreed to give a priority review to Salix Pharmaceutical's potential treatment for HIV-associated diarrhea.
The Raleigh company announced this morning that the FDA has set a June 5 target for making its decision on whether or not to approve the drug.
The FDA grants priority reviews to drugs that offer major advances in treatment or which provide treatment where no adequate therapy exists.
Salix submitted the drug, crofelemer, to the FDA for review in December. Crofelemer are 125 mg tablets used to treat diarrhea in patients with HIV or AIDS who are on anti-retroviral therapy.
Salix estimates that some 150,000 patients on the therapy experience chronic diarrhea which can cause weight loss and complicate treatment.
Salix has an agreement to develop Crofelemer with San Francisco-based Napo Pharmaceuticals.
Napo, which sued Salix last year claiming it breached their collaboration agreement, announced in November that it had terminated the agreement.
Salix calls the lawsuit baseless and says Napo's termination of the license is groundless and without merit.
Salix develops drugs that treat gastrointestinal diseases, including Xifaxan, which treats traveler's diarrhea.
Salix shares closed Monday at $48.55.