Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today reported that the
Gastrointestinal Drugs Advisory Committee of the FDA has recommended by
a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin)
Tablets, 550 mg for the maintenance of remission of hepatic
encephalopathy (HE).
“We are very pleased with the advisory committee’s support for the
approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be
the first new option for the management of hepatic encephalopathy in
over 30 years”
“We are very pleased with the advisory committee’s support for the
approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be
the first new option for the management of hepatic encephalopathy in
over 30 years,” stated Bill Forbes, Pharm.D., Senior Vice President
Research and Development and Chief Development Officer, Salix. “We
believe the availability of XIFAXAN 550 mg has the potential to change
the treatment paradigm for HE. Today’s independent recommendation from
the outside experts comprising the advisory committee reinforces the
Company’s confidence in the potential for XIFAXAN 550 mg to provide a
solution for patients suffering from this serious condition.”
The committee reviewed data from the Company’s 299-subject,
double-blind, placebo-controlled, multinational, Phase 3 study. This
study demonstrated a statistically significant and clinically meaningful
reduction in the risk of recurrent overt HE. The primary
endpoint – the risk of experiencing a breakthrough overt HE episode –
was reduced by 58 percent in XIFAXAN 550 mg-treated subjects compared
with placebo (p<0.0001). The key secondary endpoint – risk of
experiencing HE-related hospitalization – was reduced by 50 percent in
XIFAXAN 550 mg-treated subjects compared with placebo>
The FDA convenes the Gastrointestinal Drugs Advisory Committee to obtain
independent expert advice on a broad scope of issues relating to
gastrointestinal drug products. The committee provides non-binding
recommendations which will be considered by the FDA in its final review;
however, the final decision on approval of the drug is made by the FDA.
The FDA has issued an action date of March 24, 2010 under the
Prescription Drug User Fee Act for the XIFAXAN 550 mg HE NDA. XIFAXAN
has been granted Orphan Drug designation by the FDA for use in hepatic
encephalopathy. Salix believes this designation will provide seven years
of marketing exclusivity in the United States if XIFAXAN 550 mg gains
approval from the FDA for HE.
Hepatic encephalopathy occurs frequently in patients with cirrhosis as a
result of their end-stage liver disease. Typically the cirrhosis is
caused by a number of factors, such as alcohol and/or drug abuse,
chronic viral hepatitis and autoimmune disease. There are more than
600,000 cases of cirrhosis in the United States and it is a leading
cause of death in the United States. The number of cases of
liver disease in the United States and around the world is rapidly
increasing, with the estimated prevalence of chronic liver disease in
the United States believed to be between 6 and 7 million cases. There
are reported to be approximately 200,000 patients in the United States
with overt HE.
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