FDA grants priority review to Salix treatment

Salix Pharmaceuticals Ltd. said Tuesday that the Food and Drug

Administration granted a priority review to its potential treatment

for HIV-associated diarrhea.

Salix Pharmaceuticals Ltd. said Tuesday that the Food and Drug Administration granted a priority review to its potential treatment for HIV-associated diarrhea.

The Raleigh, N.C., company had submitted the oral treatment, crofelemer, to regulators for review in December. A priority review is given to drugs that may offer treatment advances or provide a treatment where no adequate therapy exists.

The FDA has set a June 5 target date for making its decision on whether to approve the drug.

Crofelemer tablets aim to treat diarrhea in patients with HIV or AIDS who are on anti-retroviral therapy. Salix estimates that about 150,000 patients on this therapy experience episodic or chronic diarrhea, which can lead to weight loss and affect compliance with the treatment.

Salix develops pharmaceutical products for gastrointestinal diseases. It also makes Xifaxan, which treats traveler’s diarrhea and neurological problems associated with liver failure. Diarrhea can lead to weight loss and affect compliance with the therapy.

Its shares finished at $48.55 per share on Monday. They have traded in a 52-week range of $25.64 to $50.28 over the past year.

  • Associated Press