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Asacol® 800 Tablets Now Available in Canada for the Treatment of Moderately Active Ulcerative Colitis |
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Toronto, ON (July 28, 2005) — P&G Pharmaceuticals Canada Inc. is pleased to announce that Asacol 800 (800 mg mesalamine, also referred to as 5-aminosalicylic acid or 5-ASA delayed release tablet) is now available at wholesalers across Canada, beginning the week of July 25, 2005. Asacol 800 is indicated for the treatment of moderately active ulcerative colitis at a recommended daily adult dose of six tablets, taken orally, in divided doses. "The 800 mg tablet contains more mesalamine per tablet than any other 5-ASA currently available in Canada," said Jeff Davis, general manager, P&G Pharmaceuticals Canada Inc. "We are delighted to be the first in Canada to offer patients suffering from this debilitating condition a more convenient dosing option by reducing the daily number of tablets in half." The demonstrated efficacy of Asacol 800 (800 mg tablet) offers patients with this moderately active disease (receiving 4.8 g/day of mesalamine) a convenient dosing over Asacol (400 mg tablet) by reducing the daily number of tablets from twelve (12) to six (6) at no additional cost to patients or drug plans. P&G Pharmaceuticals has been involved in the inflammatory bowel disease (IBD) community in Canada since 1985, with the introduction of Asacol, and has been a recognized leader in IBD ever since. Jeff Davis said that "we at P&G Pharmaceuticals have gained substantial scientific, clinical, and commercial expertise in the field of IBD management, and we continue to advance the field through ongoing clinical trials, funding of IBD research, and innovative patient education and awareness programs. With the launch of Asacol 800, we are excited about the opportunity to build on this legacy for many years to come." ALTANA Pharma Inc. will continue to partner with P&G Pharmaceuticals Canada Inc. on the promotion of Asacol and Asacol 800.
For any medical questions regarding Asacol and Asacol 800, please contact: 1-800-565-0814 About Asacol and the Asacol 800 Clinical Trial The ASCEND I (Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA) study was a randomized, controlled, phase III clinical trial comparing 4.8 g/day of mesalamine, using an investigational 800 mg tablet from P&G Pharmaceuticals, to 2.4 g/day of mesalamine, using a 400 mg Asacol tablet, for six weeks. Asacol 800, at 4.8 g/day, demonstrated superior efficacy in patients with moderately active ulcerative colitis compared with patients taking Asacol at 2.4 g/day, with a similar safety profile. Treatment success was defined as improvement from baseline at week six with either complete response (remission) or partial response (improvement) to treatment. Asacol 800, at 4.8 g/day, demonstrated an overall incidence of adverse events comparable to Asacol dosed at 2.4 g/day. Reported adverse events were generally mild and transient, and seldom resulted in discontinuation of treatment. Most commonly reported adverse events for Asacol 800 were nausea (6.1%), headache (5.4%), vomiting (4.1%) and flatulence (4.1%), while those for Asacol were headache (5.8%), abdominal pain (4.5%) and ulcerative colitis (3.9%). Patients should be made aware that ulcerative colitis rarely remits completely. Abrupt discontinuation of mesalamine therapy is not recommended and may result in relapse. Caution should be exercised in patients with hepatic dysfunction or history of renal disease. Asacol 800 is not recommended for use in patients with renal impairment. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol 800 tablets and periodically while on Asacol 800 therapy. Please refer to the Asacol 800 Product Monograph for a complete list of adverse events. The Asacol 400 mg tablet used in the 2.4 g/day arm of the study was approved in Canada in 1985. The Asacol 400 mg tablet is currently indicated for the treatment of mild to moderately active ulcerative colitis and for the maintenance of remission of mild to moderate ulcerative colitis. Asacol 800 is indicated for the treatment of moderately active ulcerative colitis. The recommended daily adult dose is six tablets, taken orally, in divided doses. Interchangeability between Asacol 800 (800 mg tablet) and Asacol (400 mg tablet) has not been established. About Ulcerative Colitis Ulcerative colitis is closely related to another condition of inflammation of the intestines called Crohn's disease. Together, they are frequently referred to as inflammatory bowel disease (IBD). Ulcerative colitis involves inflammation of the lining of the colon and rectum, and it is characterized by flares, which can vary in duration and intensity, followed by periods of remission throughout a lifetime. During a flare, the rectum and/or colon become inflamed and an increase in symptoms such as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go to the bathroom are experienced. Ulcerative colitis varies in clinical severity with patients having a mild, moderate or severe disease. The severity of the disease is used to determine the appropriate approach to therapy. While ulcerative colitis is a lifelong condition, flares can be controlled with medication. The causes of this condition are unknown, but may involve heredity, infection or the immune system. The Crohn's and Colitis Foundation of Canada reports an estimated 170,000 men and women suffer from IBD in Canada. The condition affects people of all ages, but is frequently diagnosed between the ages of 15-25 or 45-55. Most people experience periods of remission and flare-ups of the disease, often requiring long-term medication, hospitalization or surgery. Although IBD is found throughout the world, it seems to be more common in North America and northern Europe. Canada is believed to have one of the highest incidence rates of IBD in the world. About Procter & Gamble (NYSE:PG) Two billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Pampers®, Tide®, Always®, Pantene®, Bounty®, Pringles®, Swiffer®, Folgers®, Charmin®, Downy®, Iams®, Crest®, Actonel®, Olay®, Clairol® Nice 'n Easy®, Herbal Essences® and Head & Shoulders. The P&G community consists of almost 110,000 employees working in over 80 countries worldwide. P&G is one of the leading consumer products companies in Canada with over $2.1 billion in annual sales. Please visit www.pgcanada.ca for the latest news and information about P&G Canada and its brands. P&G Pharmaceuticals is a division of P&G Health Care with products such as Actonel, Didrocal, Asacol, Macrobid and Dantrium. For more information on P&G Pharmaceuticals Canada Inc., visit the company's Website at www.pgpharma.com. About ALTANA Pharma Inc. Added Value is our Active Ingredient. ALTANA Pharma adds value by improving the health of Canadians through people, innovative products and Canadian-based research. ALTANA Pharma annually reinvests over 14 percent of its sales into research in Canada in respirology, critical care and gastroenterology. Its lead product is PANTOLOC, used in the treatment of acid-related gastrointestinal disorders. Designated as A Caring Company by Imagine Canada, ALTANA Pharma is recognized as being one of Canada's Top 100 employers by Maclean's. Please visit ALTANA Pharma at www.altanapharma.ca. ALTANA Pharma Inc. is the Canadian pharmaceutical group of ALTANA AG (Germany) (NYSE:AAA). |
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