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.