Asacol® 800mg Mr Tablets Approved For Ulcerative Colitis (UC), Maintenance Of Remission Of UC And Crohn's Ileo-Colitis
Asacol 800mg MR tablets have been approved for moderately active UC patients at the new high 4.8 grams per day dose based on the ASCEND (Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA) I and II clinical trials that demonstrated Asacol 800mg MR tablets given at 4.8g per day resulted in faster symptom relief compared to 2.4g per day in moderately active UC patients.1 Median time to symptom resolution was 9 days for rectal bleeding and 12 days for resolution of abnormal stool frequency for moderately active UC patients receiving Asacol 800mg MR tablets given at 4.8g per day compared to 16 days and 15 days respectively, with those who received mesalazine 400mg tablets dosed at 2.4g per day.1 Importantly, there were no significant differences in the overall serious side effect profile with Asacol 800mg MR tablets dosed at 4.8g per day compared to mesalazine 400mg dosed at 2.4g per day.2
"This is a clinically useful advance for patients with ulcerative colitis," said Simon Travis, DPhil, FRCP, Consultant Physician and Gastroenterologist at the John Radcliffe Hospital in Oxford. "Symptoms of rectal bleeding and diarrhoea resolve faster on higher dose Asacol, without increasing side effects for acute, moderately active UC patients."
"Procter & Gamble is delighted to bring this new option to ulcerative colitis patients," said Hans van Zoonen, Vice President Pharmaceuticals and Personal Healthcare, Europe. "We firmly believe that Asacol 800mg MR tablets will bring faster symptom relief to moderately active UC patients. The development of the 800mg tablet is part of our commitment to provide patients with more dosing choice and convenient options. Asacol is a key pillar to our growing GI franchise, one of three strategic focus areas within P&G Pharmaceuticals," he added.
Asacol 800mg MR tablets are indicated for the treatment of mild and moderate acute exacerbations of ulcerative colitis, to be administered at 2.4g/day and 4.8g/day, respectively, in divided doses. Asacol 800mg MR tablets, administered up to 2.4g/day, are also indicated for the maintenance of remission of ulcerative colitis and Crohn's ileo-colitis.
Procter & Gamble will advise healthcare professionals as soon as the new product is available for prescription to patients.
References
1. Marion JF et al., Gut 2006; 55(Suppl II): Abstract 140
2. Hanauer SB et al., Can J Gastroenterol2005; 19(Supp C): Abstract R.0471
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Procter & Gamble has a rich heritage in health care that extends back more than 150 years. Then and now, P&G is driven by our mission to improve the lives of people around the world every day. P&G's health care products include prescription medicines, over-the-counter medications and oral care products. P&G began developing and marketing prescription products in the late 1960s.
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About Asacol and Asacol 800mg MR Clinical Trials
Data analysis is from the combined results of two double-blind, randomised, multi-site, 6- week, controlled clinical trials designed to assess the safety and efficacy of 4.8 g/day modified-release mesalazine with an 800mg tablet compared to 2.4 g/day modified-release mesalazine with a 400mg tablet for the treatment of moderately active ulcerative colitis.
The two ASCEND (Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA) studies demonstrated that for patients with moderately active ulcerative colitis, beginning treatment with twice the standard dose of mesalazine, 4.8 grams per day with a new 800mg tablet rather than 2.4 grams per day using a 400mg mesalazine tablet for six weeks, resulted in faster symptom relief for moderately active UC patients with no increase in side effects.
Treatment success was defined as improvement from baseline at week six with either complete response (remission) or partial response (improvement) to treatment.
Asacol 800mg MR tablets, at 4.8 g/day, demonstrated an overall incidence of adverse events comparable to mesalazine 400mg tablets 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 800mg MR tablets were nausea (6.1%), headache (5.4%), vomiting (4.1%) and flatulence (4.1%), while those for mesalazine 400mg tablets 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 mesalazine therapy is not recommended and may result in relapse. Asacol 800mg MR tablets are contraindicated in patients with a history of sensitivity to salicylates or renal sensitivity to sulphasalazine, confirmed severe renal impairment (GFR less than 20 ml/min), hypersensitivity to any of the ingredients, severe hepatic impairment, gastric or duodenal ulcer and haemorrhagic tendency. Asacol 800mg MR tablets should be used with extreme caution in patients with confirmed mild to moderate renal impairment. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol 800mg MR tablets and periodically while on Asacol 800mg MR tablet therapy. Please refer to the Asacol 800mg MR tablet Summary of Product Characteristics for a complete list of adverse events.
Asacol 800mg MR tablets are indicated for the treatment of mild acute exacerbations of ulcerative colitis, and for the treatment of moderate acute ulcerative colitis to be administered at 2.4g/day and 4.8g/day, respectively, in divided doses. Asacol 800mg MR tablets, administered at 2.4g/day, are also indicated for the maintenance of remission of ulcerative colitis and Crohn's ileo-colitis in divided doses.
Interchangeability between Asacol 800mg MR tablets and Asacol 400mg MR tablets has not been established.
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Asacol ? 800mg domnul Tabletele aprobat pentru Ulcerative colita (UC), menþinerea remiterea UC ªi Crohn's Ileo-colita - Asacol® 800mg Mr Tablets Approved For Ulcerative Colitis (UC), Maintenance Of Remission Of UC And Crohn's Ileo-Colitis - articole medicale engleza - startsanatate