RALEIGH, N.C. -- Salix Pharmaceuticals Ltd. said Wednesday that
the Food and Drug Administration approved its drug Fulyzaq, which is
designed to treat diarrhea in patients taking HIV and AIDS drugs. Its
shares rose more than 5% in midday trading.
Salix said it plans to
start marketing the drug in early 2013. The company said Fulyzaq could
have up to five years of marketing exclusivity, meaning similar products
won't be approved in that time.
The drug is designed to treat
diarrhea in patients with HIV or AIDS who are on anti-retroviral
therapy. Salix says 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.
Salix said Fulyzaq, or
crofelemer, is 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, and is 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 rose
$2.10, or 5.2%, to $42.57 as the markets moved higher in midday trading.
They peaked for the past year at $55.99 in March, and traded as low as
$37.52 in early November.