“Actonel 35 mg once-a-week is a valuable new tool for the treatment and prevention of postmenopausal osteoporosis,” said Robert Lindsay, M.D., Ph.D., Chief of Internal Medicine at Helen Hayes Hospital, Professor of Clinical Medicine, Columbia University, and principal investigator of the Actonel once-a-week approval study. “Patients and doctors always welcome effective new treatment choices, and we now have data that show once-a-week dosing of Actonel is therapeutically equivalent to daily 5 mg dosing."
The FDA based its approval on safety and efficacy data from a one-year, double-blind, multicenter study that included 1,456 postmenopausal women with osteoporosis and compared the effects of the once-a-week and daily dosing of Actonel on bone mineral density (BMD). Patients taking Actonel 35 mg once-a-week experienced a significant increase in lumbar spine BMD at 12 months versus baseline -- an increase that was similar to that achieved with the Actonel 5 mg daily dose. There was also a significant increase in BMD versus baseline at the hip at 12 months, an increase that was similar in both treatment groups.
The overall safety and tolerability profiles of Actonel 35 mg once-a-week and 5 mg daily were similar in the study. Consistent with other pivotal Actonel clinical studies, patients were not excluded based on a history of, or active, GI disease.
About Actonel
Actonel is co-developed and co-marketed by Procter & Gamble Pharmaceuticals and Aventis Pharmaceuticals. Actonel 35 mg once-a-week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (7.5 mg/d prednisone or equivalent) for chronic diseases.
In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia 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 renal impairment (creatinine clearance < 30 mL/min).
Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.
In clinical trials, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7 percent vs. Actonel 5 mg 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and arthralgia (21.1 percent vs. 23.7 percent).
In a one-year clinical trial comparing Actonel 35 mg once-a-week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6 percent vs. Actonel 5 mg 19.0 percent), arthralgia (14.2 percent vs. 11.5 percent) and constipation (12.2 percent vs. 12.5 percent).
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis Pharma in May 1997 to develop and market Actonel collaboratively in Europe, the United States and Canada. The Alliance promotes bone health and disease awareness through numerous activities to support physicians and patients around the globe.
About Procter & Gamble Pharmaceuticals
Procter & Gamble Pharmaceuticals is a part of Procter & Gamble Health Care, a division of The Procter & Gamble Company (NYSE:PG) – a $40 billion global leader in the development, manufacturing and marketing of a broad range of consumer goods. In prescription drugs, P&G is focusing in the areas of endocrinology, cardiovascular and musculoskeletal diseases, as well as anti-infective therapies. Some of P&G’s leading prescription products include Actonel, Didronel (etidronate disodium), Asacol (mesalamine) and Macrobid (nitrofurantoin monohydrate macrocrystals).
About Aventis Pharmaceuticals
Aventis Pharmaceuticals conducts the U.S. prescription drug business of Aventis. With headquarters in Bridgewater, N.J., Aventis Pharmaceuticals focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, osteoporosis, allergy and respiratory, diabetes, and the central nervous system.
Aventis (NYSE: AVE) is dedicated to improving life by treating and preventing human disease through the discovery and development of innovative pharmaceutical products. Aventis focuses on prescription drugs for important therapeutic areas such as oncology, cardiology, diabetes and respiratory disorders as well as on human vaccines. In 2001, Aventis generated sales of € 17.7 billion ($15.9 billion), invested approx. € 3 billion ($2.7 billion) in research and development and employed approx. 75,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. For more information, please visit: www.aventis.com.
Please see full prescribing information for Actonel by visiting www.actonel.com. Copies of this release are available on the Aventis Pharmaceuticals U.S. Web site at http://www.aventispharmaus.com, or call 800/207-8049.
Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.
Contact: Mary Johnson
Procter & Gamble Pharmaceuticals
(513) 622-5291
johnson.mb.3@pg.com
Susan Brooks
Aventis Pharmaceuticals
(908) 243-7564
susan.brooks@aventis.com