The US FDA has granted marketing approval for Salix Pharmaceuticals' 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," stated Bill Forbes, Vice President, Research and Development, and Chief Development Officer. "We believe OsmoPrep provides a more desirable alternative for physicians and patients who would prefer a virtually tasteless tablet cleansing agent over difficult-to-tolerate liquid cleansing agents such as four-litre PEG products and OTC sodium phosphate. This unique tablet formulation has been demonstrated to improve patient compliance and satisfaction. We are pleased to be able to offer the new OsmoPrep Tablet bowel cleansing prep for colonoscopy," he added.
Douglas Rex, Professor of Medicine, Indianapolis University School of Medicine and Director of Endoscopy, Indiana University Hospital, stated, "OsmoPrep provides excellent colon cleansing in a highly tolerable tablet formulation making colonoscopies simple for both the physician and the patient. It represents a new choice for patients unable to tolerate high volume liquid preparations."
Carolyn Logan, President and Chief Executive Officer stated, "We consider OsmoPrep to be a key addition to our portfolio designed to provide important and effective products to gastroenterologists and their patients. Salix continues to build its therapeutic franchise in gastrointestinal disease by developing and securing marketing approval for additional products. OsmoPrep, Colazal and Xifaxan, Salix's three primary growth drivers, now combine to create the focus of our product portfolio. Our 96 specialty sales representatives are strategically positioned to maximize the commercial potential these products hold for the Company."
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. Today less than half of adults age 50 and older in the US 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.