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Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine)Delayed-Release Tablets

By Pharmaceutical Processing | July 7, 2009

Procter & Gamble Pharmaceuticals (P&GP)has announced the availability of Asacol HD (mesalamine) delayed-releasetablets, which are indicated for the treatment of moderately active ulcerativecolitis (UC), a form of inflammatory bowel disease. UC involves inflammationof the lining of the colon and rectum and is typically characterized by flaresfollowed by periods of remission. Moderately active UC is characterized bytougher symptoms than mildly active UC. Asacol HD is proven to help treatthese tougher flares of moderately active UC. Asacol HD was approved by theU.S. Food and Drug Administration (FDA) based on evaluations from the ASCENDstudies 1/8Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA(4.8 g/day 800 mg tablet)3/8. In six-week clinical studies of moderately active UC flares, Asacol HD at4.8 g/day helped many patients reduce their UC symptoms, including number ofbowel movements and rectal bleeding, for some as early as three weeks. AsacolHD decreased the number of trips to the bathroom (i.e., number of bowelmovements) in approximately three out of four of patients by six weeks anddecreased rectal bleeding for approximately 80 percent of patients by sixweeks. Patients should discuss their experiences with Asacol HD with aphysician, as their individual results may vary. “In six-week clinical trials of moderately active UC, Asacol HD helpedreduce rectal bleeding and stool frequency, without the use of steroids. Theseencouraging results help support Asacol HD as an effective therapy in patientswith moderately active UC,” said Stephen B. Hanauer, M.D., Chief ofGastroenterology, Hepatology and Nutrition at the University of ChicagoMedical Center. “Every patient’s disease is different and requires a personalapproach to treatment. A course of treatment that is right for one patient maynot be right for another. Patients should speak with their doctors todetermine the course of therapy that is best for them.” P&GP has been a leader in UC research and education through support ofprofessional UC programs and research grants. P&GP is also the maker ofAsacol(R) (mesalamine) 400 mg delayed-release tablets, the number onemost-prescribed oral 5-aminosalicylic acid (5-ASA) therapy.… More than 20million prescriptions have been written for Asacol since its FDA approval andU.S. launch in 1992.…… Physicians have relied on Asacol as a trusted UCtherapy for more than 17 years. Asacol HD is the newest addition to P&GP’s GIportfolio. “Procter & Gamble is delighted to introduce Asacol HD to the Asacolfranchise. This new addition will further help UC patients get their symptomsunder control so that their lives can be more predictable,” said Dan Hecht,General Manager for P&G Pharmaceuticals, North America. “This addition toP&G’s robust portfolio of gastrointestinal therapies underscores P&G’scontinued commitment to developing innovative ways to improve the lives ofmillions of people that struggle with GI conditions every day.”

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