Salix: FDA gives marketing approval for OsmoPrep Tablets

By Ted A. Knutson

Washington, March 17 - Salix Pharmaceuticals, Ltd. said Friday the Food and Drug Administration has granted marketing approval for prescription OsmoPrep Tablets (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP).

OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older.

OsmoPrep is patent protected until 2013, and additional patent protection is being sought through 2024.

"The approval of OsmoPrep is an important step forward in our effort to provide a product that makes bowel preparation for colonoscopy as effective, tolerable, easy and convenient as possible for patients," said Bill Forbes, vice president of research and development and chief development officer for Salix, in a news release.

The majority of colonoscopies performed in the United States are indicated for colorectal cancer screening, and more than 10 million uses of bowel cleansing agents were prescribed during 2005.

Less than half of adults age 50 and older in the United States undergo recommended colorectal cancer screening. Colonoscopy is very effective in the early detection of colorectal cancer, and about 90% of colorectal cancers and deaths are preventable if detected early. The American Cancer Society estimates that more than 30,000 lives could be saved annually as a result of widespread screening. Results of a study conducted by the Mayo Clinic demonstrated that patient unwillingness to take a bowel preparation is the single largest barrier to colorectal cancer screening, the company added.

Salix is a Raleigh, N.C.-based biotech company.

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