(By Balaseshan) The U.S. Food
and Drug Administration today approved Salix Pharmaceuticals Ltd.'s (NASDAQ: SLXP)
anti-diarrheal drug for HIV/AIDS patients.
The FDA approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea
in HIV/AIDS patients taking antiretroviral therapy, a combination of
medicines used to treat HIV infection. Fulyzaq, which is derived from
the red sap of the Croton lechleri plant, is the second botanical
prescription drug approved by FDA.
A botanical drug product is often a complex mixture derived from one
or more plant materials with varying degrees of purification. In 2006,
the FDA approved the first botanical prescription drug, Veregen
(sinecatechins), a treatment for external genital and perianal warts.
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Fulyzaq is distributed by Salix Pharmaceuticals based in Raleigh,
North Carolina under license from Napo Pharmaceuticals Inc. Veregen is
marketed by Florham Park, New Jersey-based PharmaDerm.
experienced by many HIV/AIDS patients and is a common reason why
patients discontinue or switch their antiretroviral therapies. Fulyzaq
is intended to be used in HIV/AIDS patients whose diarrhea is not caused
by an infection from a virus, bacteria, or parasite.
The safety and efficacy of Fulyzaq were established in a clinical
trial of 374 HIV-positive patients on stable antiretroviral therapy with
a history of diarrhea lasting one month or longer.
[Related -Salix Pharma (SLXP): FDA Approves Therapy For ART-Related Diarrhea In HIV Positive Patients]
The trial was
designed to measure clinical response, defined as the number of patients
who had two or fewer watery bowel movements weekly. Results showed that
17.6% of patients taking Fulyzaq experienced clinical response compared
with 8% taking placebo. In some patients, a persistent anti-diarrheal
effect was seen for 20 weeks.
Common side effects reported in patients taking Fulyzaq in the
clinical trial were upper respiratory tract infection, bronchitis,
cough, flatulence, and increased levels of the liver enzyme bilirubin.
SLXP is trading up 1.01% at $40.09 on Monday. The stock has been trading between $37.52 and $55.99 for the past 52 weeks.