To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Actonel (Risedronate) For Osteoporosis URL: http://www.pslgroup.com/dg/1CD17E.htm Doctor's Guide April 17, 2000
CINCINNATI, OH and PARSIPPANY, NJ -- April 17, 2000 -- Procter & Gamble and Aventis Pharmaceuticals, the U.S. pharmaceutical business of Aventis S.A. announced that the U.S. Food and Drug Administration (FDA) approved 5 mg Actonel(R) (risedronate sodium tablets) for the treatment and prevention of postmenopausal osteoporosis (PMO) and glucocorticoid-induced osteoporosis (GIO). Procter & Gamble, the inventor of Actonel, and Aventis Pharmaceuticals will market the drug collaboratively. The approval of Actonel is important to physicians and patients because: -- Actonel is the first osteoporosis therapy to consistently demonstrate a reduction in vertebral (spinal) fracture incidence in just one year of treatment. New data show that almost 20 percent of untreated patients who experience a vertebral fracture will fracture again in just one year. -- Actonel significantly reduced the risk of new vertebral fractures by 65 percent in one year in postmenopausal women compared to a control group of women taking supplemental calcium and, if needed, vitamin D (6.4 percent of patients in the control group and only 2.4 percent of patients taking Actonel fractured, a reduction in absolute risk of four percentage points) . -- This one-year vertebral fracture benefit has been consistently seen across several Actonel studies. Additionally, Actonel is the only therapy to show this one-year vertebral fracture benefit in patients with GIO as well. -- "New understanding about osteoporosis suggests it progresses much faster than was originally thought, demonstrating the clear need for fast-acting therapies," said Robert Lindsay, MD, Ph.D., College of Physicians and Surgeons, Department of Medicine, Columbia University, New York, NY. "With Actonel, patients who act quickly to get diagnosed and treated can significantly reduce their risk of vertebral fractures within just one year." -- Actonel was well-tolerated, even in patients with gastrointestinal (GI) diseases. The clinical trials for Actonel included patients with gastrointestinal (GI) disease-including ulcers, esophagitis, and heartburn-and those taking nonsteroidal anti-inflammatory drugs (NSAIDs), which often cause GI complaints. In fact, more than 60 percent of patients in the Actonel clinical trials reported regular use of NSAIDs or aspirin during the clinical studies, and almost 40 percent of patients had ongoing GI disease. Even among these patients, the incidence of GI side effects in Actonel treated patients was similar to that of patients taking placebo (sugar pill). New science shows that a vertebral fracture increases the risk of additional fractures within just one year. "It is unacceptable to allow this 'domino effect' of fractures to continue," said Mark A. Collar, president, Procter & Gamble Pharmaceuticals Worldwide. "The demonstrated efficacy of Actonel to consistently reduce vertebral fractures in as little as one year is a major advance in the treatment of osteoporosis." Experts know that although many women take calcium, eat right and exercise, these steps are typically not enough to protect the majority from osteoporosis-related fractures. "Because of the aging population, osteoporosis is now a major public health issue; however, the vast majority of women with osteoporosis still go undiagnosed," said Gerald P. Belle, president of Aventis Pharmaceuticals North America. "Now more than ever, it is critically important that healthcare professionals recognize the urgency to diagnose and treat osteoporosis." In studies of women with postmenopausal osteoporosis, Actonel significantly reduced the risk of new vertebral fractures in just one year. In high-risk patients (greater than or equal to two previous vertebral fractures), Actonel significantly reduced the risk of vertebral fractures by up to 74 percent in just one year (9.8 percent of patients in the control group and only 2.7 percent of patients taking Actonel fractured, a reduction in absolute risk of 7.1 percentage points). Reductions of vertebral fracture risk were seen throughout the three-year study duration. All patients in both the PMO and GIO studies received supplemental calcium and some also received supplemental Vitamin D. Actonel is indicated for the prevention and treatment of glucocorticoid- induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoid treatment (daily dosage equivalent to 7.5 mg or greater of prednisone) for chronic diseases. The efficacy of Actonel in patients with GIO was tested in two studies with men and women taking oral glucocorticoid steroids for diseases such as rheumatoid arthritis. Combined results from the studies demonstrated that treatment with Actonel for one year significantly reduced vertebral fractures by 70 percent (16.2 percent of patients in the control group and only 5.4 percent of patients taking Actonel fractured, a reduction in absolute risk of 10.8 percentage points). This is the first data of its kind and is important because approximately one in six patients initiating glucocorticoid therapy will suffer a vertebral fracture within one year, and up to 50 percent of patients on chronic glucocorticoid therapy will suffer a fracture. Actonel is the first therapy ever approved for the prevention of GIO. Actonel is the second bisphosphonate invented by Procter & Gamble, which pioneered the use of this class of drug in bone disease with etidronate, currently marketed in 22 countries under the name Didronel(R). "The approval of Actonel in the U.S. represents a significant milestone for our healthcare business," said P&G chairman, president, and CEO Durk I. Jager. "It's a great example of our ability to leverage superior science and technology from across our company to improve the lives of the world's consumers." To date, 15 countries worldwide have agreed to recognize the approval of Actonel for the treatment of established PMO to reduce the risk of vertebral fractures, for the prevention of osteoporosis in postmenopausal women at increased risk of osteoporosis, and to maintain or increase bone mass in postmenopausal women undergoing long-term glucocorticoid treatment. Actonel should not be used in patients with low blood calcium, known allergy to Actonel or an inability to stand or sit upright for at least 30 minutes. Low blood calcium and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe kidney disease. Bisphosphonates may cause upper gastrointestinal disorders, such as dysphagia (difficulty swallowing), esophagitis (irritation of the esophagus) and esophageal or gastric ulcers. Patients should take Actonel with a full glass of plain water (6-8 oz.) to facilitate delivery to the stomach, and should not lie down for 30 minutes after taking the drug. In clinical trials, Actonel was generally well tolerated. Most side effects were mild to moderate and did not require patients to stop taking Actonel. Overall, side effects were comparable to placebo and included infection (primarily upper respiratory) and back and joint pain. The Alliance for Better Bone Health, P&G, and Aventis Pharma P&G, and Aventis Pharma formed The Alliance for Better Bone Health in May 1997 to develop and market Actonel collaboratively. Procter & Gamble Pharmaceuticals is a part of Procter & Gamble Health Care, a division of The Procter & Gamble Company - a $38 billion global leader in the development, manufacturing and marketing of a broad range of consumer goods. In prescription drugs, P&G is focusing on musculoskeletal and cardiovascular health, as well as anti-infective therapies. Some of P&G's leading prescription products include Didronel(R) (etidronate disodium), Asacol(R) (mesalamine) and Macrobid(R) (nitrofurantoin monohydrate/macrocrystals). Aventis Pharmaceuticals conducts the U.S. business of Aventis Pharma AG, the pharmaceutical company of Aventis S.A.. Aventis Pharmaceuticals is dedicated to treating and preventing human disease through the discovery, development, manufacture and sale of innovative pharmaceutical products aimed at satisfying unmet medical needs. Headquartered in Parsippany, NJ, Aventis Pharmaceuticals focuses on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory disorders, diabetes and the central nervous system. One of the world's leading life sciences companies, Aventis S.A. is focused on two core business areas: pharmaceuticals and agriculture. Aventis corporate headquarters is in Strasbourg, France. 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