Rifaximin branded as Xifaxan has been recommended for approval to treat hepatic encephalopathy in US, Salix Pharmaceuticals, Ltd announced.
The Gastrointestinal Drugs Advisory Committee of US FDA has recommended by a vote of 14 to 4 in favor of the approval of rifaximin (Xifaxan) tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).
“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, in a press release.
Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens.
The study demonstrated a statistically significant and clinically meaningful reduction in the risk of recurrent overt hepatic encephalopathy.
The risks of experiencing a breakthrough overt hepatic encephalopathy episode and hospitalizations were reduced by over 50 percent in Xifaxan 550 mg-treated subjects.
US 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.
US FDA has issued an action date of March 24, 2010 under the Prescription Drug User Fee Act for the Xifaxan 550 mg HE NDA.
Rifaximin (Xifaxan) has been granted Orphan Drug designation by the FDA for use in hepatic encephalopathy.
What is hepatic encephalopathy?
Hepatic encephalopathy (HE) is a neurological disorder caused by chronic liver failure resulting in cognitive, psychiatric and motor impairments.
The condition encompasses a wide spectrum of often reversible neuropsychiatric abnormalities caused by the inability of the liver to remove toxic products in the gut, most notably ammonia produced by bacteria in the GI tract.
when toxins… ADD HERE
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.
Rifaximin tablets 200 mg, which Salix markets in the United States under the trade name Xifaxan tablets 200 mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers’ diarrhea (TD) caused by non–invasive strains of Escherichia coli.
Rifaximin has been used in Italy for 24 years and is approved in 33 countries.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NC, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.
Salix in-licenses late-stage or marketed proprietary therapeutic drugs, complete with any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.
Salix also markets Moviprep (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), Visicol (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, Osmoprep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, Apriso (mesalamine) extended-release capsules 0.375 g., Metozolv ODT (metoclopramide HCl), Pepcid (famotidine) for Oral Suspension, Oral Suspension Diuril (Chlorothiazide), Azasan (azathioprine Tablets, USP, 75/100 mg, Anusol-HC 2.5% (Hydrocortisone Cream, USP), Anusol-HC 25 mg Suppository (Hydrocortisone Acetate), Proctocort Cream (Hydrocortisone Cream, USP) 1% and Proctocort Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer, budesonide foam and rifaximin for additional indications are under development.