Safety and Efficacy Results Presented From Largest Prospective Controlled Clinical Study of Ulcerative Colitis4.8 g/day dose using investigational 800 mg tablet demonstrated efficacy and was well tolerated in ASCEND III study
SAN DIEGO, May 20, 2008 /PRNewswire-FirstCall/ -- In a study presented today at the 39th Annual Digestive Disease Week (DDW) meeting in San Diego, California, 70 percent of patients with moderately active ulcerative colitis (UC) receiving an investigational 800 mg mesalamine tablet dosed at 4.8 g/day under development by Procter & Gamble Pharmaceuticals experienced overall improvement in disease measures. In the study, the investigational tablet and dose were compared to 400 mg mesalamine tablets dosed at 2.4 g/day.
Additionally, patients in the study with a clinical history of more difficult-to-treat disease, such as those who have been previously treated with steroids and/or rectal therapies, received benefit from the investigational 800 mg tablets dosed at 4.8 g/day. Adverse events seen with the investigational 800 mg tablet dosed at 4.8 g/day were comparable to the 400 mg tablet dosed at 2.4 g/day and the discontinuation rate due to adverse events was no different between the two treatments (both 3.9 percent).
"The ASCEND III study is important because it helps us understand which patients may benefit from higher doses of mesalamine," says Dr. Stephen Hanauer, professor of medicine and clinical pharmacology chief, The Medical Center. "In this study the investigational 800 mg mesalamine tablet dosed at 4.8 g/day was well-tolerated and helped patients with moderately active UC manage their symptoms."
The ASCEND III study, which was discussed during an oral presentation at DDW today, was designed to further evaluate the clinical benefit of the investigational 800 mg tablet dosed at 4.8 g/day by assessing the non-inferiority of the 4.8 g/day dose versus the 2.4 g/day dose (400 mg mesalamine tablets). The primary endpoint was met -- the investigational 800 mg tablet dosed at 4.8 g/day was efficacious and non-inferior to the 400 mg mesalamine tablet dosed at 2.4 g/day. At Week 6, overall improvement was achieved by 70 percent of patients with moderately active UC on the investigational 800 mg mesalamine tablet (dosed at 4.8 g/day). Overall improvement was determined by clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy.
"These promising data presented at DDW will hopefully support the approval of a new treatment option for patients with moderately active ulcerative colitis," said David Lacy, GI category director for Procter & Gamble. "As a company, we are committed to GI research that will help us offer patients new treatment options and further advance understanding of how to best manage various GI conditions that negatively impact the lives of millions of people every day."
Additional Study Details
An oral presentation on May 20 announced findings from ASCEND III, a Phase III, 6-week, double-blind, randomized, multi-national, active-control study designed to evaluate the non-inferiority of the investigational 800 mg tablet dosed at 4.8 g/day versus the 400 mg mesalamine tablet dosed at 2.4 g/day in patients with moderately active UC (Physician's Global Assessment [PGA] = 2). The primary endpoint was overall improvement defined as improvement from baseline at six weeks in the PGA (which was based on the clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy) and no worsening in any of the individual clinical assessments. A total of 772 patients were randomized and dosed. The primary objective of non-inferiority was met and overall improvement was seen in 70 percent (273/389) of patients receiving the 800 mg tablet dosed at 4.8 g/day as compared to 66 percent (251/383) of patients receiving the 400 mg tablet dosed at 2.4g/day. In the study the investigational 800 mg tablet dosed at 4.8 g/day also demonstrated efficacy in secondary endpoints: clinical remission, rectal bleeding, stool frequency and sigmoidoscopy improvement.
About Ulcerative Colitis (UC)
UC involves inflammation of the lining of the colon and rectum. It varies in clinical severity with patients having mild, moderate or severe disease. Treatment depends on the extent and severity of disease.
UC causes flares followed by periods of remission. During a flare, in which the rectum or colon become inflamed, people experience symptoms such as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go to the bathroom. Flares can vary in duration and intensity. While UC is a lifelong condition, medication may help control flares.
UC affects people of all ages, but is often diagnosed during early adulthood. The causes of this condition are unknown, but may involve heredity, infection and/or the immune system.
About Procter & Gamble
Procter & Gamble Pharmaceuticals, Inc. (P&GP), a division of The Procter & Gamble Company , has successfully developed and marketed a wide range of prescription products since the 1980s, including Actonel(R) (risedronate sodium) tablets, Asacol(R) (mesalamine) delayed-release tablets, Dantrium(R) (dantrolene sodium) capsules, Didronel(R) (etidronate disodium) tablets, Enablex(R) (darifenacin) extended release tablets and Macrobid(R) (nitrofurantoin monohydrate/macrocrystals) capsules. P&GP employs a Connect + Develop model for new product development through which it in-licenses or acquires 100 percent of its new drug development projects from biotech and pharmaceutical industry relationships. P&GP is committed to leveraging this model to build brands to address unmeet needs in the areas of gastrointestinal, musculoskeletal and women's health. The P&GP community consists of more than 3,000 employees working in over 22 countries worldwide. For more information on P&GP and its prescription product portfolio, please visit www.pgpharma.com
Three billion times a day, P&G brands touch the lives of people around the world. P&G has one of the strongest portfolios of trusted brands in consumer health and wellness, including Align(R), Always(R), Crest(R), Metamucil(R), Oral-B(R), Pepto-Bismol(R), Prilosec OTC(R), Scope(R), Tampax(R) and Vicks(R), in addition to its other leadership consumer brands, including Ariel(R), Braun(R), Bounty(R), Charmin(R), Dawn(R), Downy(R), Duracell(R), Folgers(R), Gillette(R), Head & Shoulders(R), Iams(R), Lenor(R), Mach3(R), Olay(R), Pantene(R), Pampers(R), Pringles(R), Tide(R), Wella(R) and Whisper(R). The P&G community consists of more than 135,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
About Digestive Disease Week (DDW)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org
Jeff McDowell - P&G Pharmaceuticals, Inc. +1-513-622-5583
Danielle Brown - Manning, Selvage & Lee PR +1-212-468-3194
CONTACT: Jeff McDowell of P&G Pharmaceuticals, Inc., +1-513-622-5583, orDanielle Brown of Manning, Selvage & Lee PR, +1-212-468-3194, for Procter &Gamble
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Posted: May 2008