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FDA approves Actonel for once-a-week use

Cincinnati, Ohio; Bridgewater, N.J. (May 20, 2002) - The FDA has approved a new 35 mg once-a-week dosage strength for Actonel (risedronate sodium tablets) for the prevention and treatment of postmenopausal osteoporosis. This approval offers patients the convenience of a once-a-week dosing option to manage their osteoporosis and protect their bones. It will be available in mid-June 2002, by prescription only.

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.


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Contact: Ashley Donnelly
adonnelly@hillandknowlton.com
212-885-0488
Hill and Knowlton
20-May-2002


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